[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t2dm-type-2-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t2dm-type-2-diabetes-mellitus":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,44,66,96,120,154,174,197,219,240,260,280,311,333,354,385,413,437,461],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100622961","duodenal-pulsendo-for-suboptimally-controlled-type-ii-diabetes-mellitus-and-steatotic-liver-disease-100622961",false,"NCT07390422","Duodenal pulsENDO for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease","Duodenal Recellularization Via Electroporation Therapy for Suboptimally Controlled Type II Diabetes Mellitus and Steatotic Liver Disease (DRESS-1 Study)","DRESS-1","Inclusion Criteria:\n\n* Duration of T2DM \\\u003C 10 years\n* BMI 18.5-40kg\u002Fm2\n* Failure to achieve adequate HbA1c reduction (7.5 - 11%) after at least 3 months stable dosage of oral glucose lowering drugs\n\nExclusion Criteria:\n\n* Previous treatment with pulsENDO or similar procedure\n* Previous GI surgery that could preclude the ability to perform pulsENDO, or acute gastric and duodenal pathology that increased the risk of pulsENDO\n* Type 1 DM, DM secondary to specific disease or having any history of ketoacidosis\n* Patients on insulin\n* Fasting C-peptide level \\\u003C0.5ug\u002FL\n* Any inflammatory disease of the gastrointestinal tract such as Crohn's disease\n* Abnormal pathologies or conditions of the gastrointestinal tract, including duodenal polyps, ulcers or upper gastrointestinal bleeding conditions within 3 months of study\n* Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000\u002Fmicroliter or known coagulopathy\n* Currently taking prescription antithrombotic therapy (e.g., anticoagulant or antiplatelet agent) within 10 days prior to study and\u002For there is a need or expected need to use during the study period\n* Currently taking medications known to cause significant weight gain or weight loss (e.g. chemotherapeutics)\n* Patients who have used non-steroidal analgesics and anti-inflammatory drugs (NSAID) and corticosteroids in the past 1 month\n* Underlying uncontrolled endocrine problem that leads to obesity, including and not limited to hypothyroidism, Cushing syndrome and eating disorder.\n* Patients with contra-indications to endoscopy\n* Patients with cirrhosis due to causes other than MASLD\n* Malignancy\n* Diagnosis of autoimmune connective tissue disorder (e.g. lupus erythematosus, scleroderma)\n* Pregnant or breast feeding\n* ASA grade IV \\& V\n* Mental or psychiatric disorder; Drug or alcohol addiction\n* Other cases deemed by the examining physician as unsuitable for safe treatment\n* Refusal to participate","ALL","18 Years","70 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study is designed to evaluate the efficacy, safety, and mechanisms of pulsENDO procedure in patients with T2DM and its effect on MASLD.",[28,29,30],"T2DM (Type 2 Diabetes Mellitus)","MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Metabolic Syndrome (MetS)","NOT_YET_RECRUITING","2026-06-20",{"date":34,"type":35},"2026-06-24","ACTUAL",{"date":37,"type":22},"2026-09-01",{"date":39,"type":22},"2033-08-30",{"name":41,"class":42},"Chinese University of Hong Kong","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":43},"100641317","anti-inflammatory-dietary-intervention-in-patients-with-type-2-diabetes-a-randomized-controlled-trial-100641317","NCT07656805","Anti-inflammatory Dietary Intervention in Patients With Type 2 Diabetes: A Randomized Controlled Trial","Evidence-based Construction and Application of an Anti-inflammatory Diet Intervention for Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n1. Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) according to the Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus in China (2020 Edition);\n2. Aged 18 years or older;\n3. Able and willing to complete all study questionnaires;\n4. Willing to provide blood samples for laboratory testing;\n5. Possessing adequate communication and comprehension abilities, with no impairment of consciousness, and able to respond to investigators' questions;\n6. Willing to participate in regular follow-up visits and assessments according to the study protocol and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Patients with a history of diseases affecting blood glucose metabolism, such as hyperthyroidism or Cushing's syndrome;\n2. Pregnant or breastfeeding women;\n3. Patients with severe hepatic dysfunction, renal dysfunction, heart failure, or malignant tumors;\n4. Patients with acute or chronic infectious diseases accompanied by obvious signs of infection, including clinically diagnosed intestinal infections, respiratory tract infections, periodontitis, and other infectious conditions;\n5. A history of recent use of medications that may affect inflammatory or metabolic status, such as nonsteroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin) or glucocorticoids;\n6. Patients who have undergone gastrointestinal surgery or have diseases that may affect the effectiveness of dietary intervention, such as malabsorption syndrome.",{"count":52,"type":22},88,[25],"The goal of this clinical trial is to evaluate whether an evidence-based anti-inflammatory dietary intervention can reduce inflammation and improve glycemic control in patients with type 2 diabetes mellitus (T2DM). T2DM is a chronic metabolic disease characterized by elevated blood glucose levels and is closely associated with chronic low-grade inflammation.\n\nThe main questions it aims to answer are:\n\nDoes an anti-inflammatory dietary intervention reduce levels of hs-CRP, a key marker of chronic inflammation, in patients with T2DM? Does the intervention improve dietary inflammatory index (DII) scores and glycemic outcomes, including fasting blood glucose and 2-hour postprandial blood glucose? Researchers will compare an anti-inflammatory diet intervention group to a standard diabetes dietary control group to determine whether the anti-inflammatory dietary pattern provides additional benefits beyond routine dietary management.\n\nParticipants will:\n\nBe randomly assigned to either the anti-inflammatory diet group or the standard diabetes diet group Receive dietary guidance based on structured anti-inflammatory food recommendations or routine diabetes dietary advice Complete dietary assessments, including 24-hour dietary recalls to calculate dietary inflammatory index (DII) Provide blood samples to measure hs-CRP, fasting blood glucose, and 2-hour postprandial blood glucose at baseline and after 4 weeks Complete questionnaires on dietary adherence and quality of life Participate in a 4-week intervention period with follow-up assessments",[28],"RECRUITING","2026-06-14",{"date":59,"type":35},"2026-06-18",{"date":61,"type":35},"2026-06-03",{"date":63,"type":22},"2026-11",{"name":65,"class":42},"Anhui Medical University",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100616299","phase-2-a-study-of-chiglitazar-in-patients-with-metabolic-dysfunction-associated-steatohepatitis-and-type-2-diabetes-mellitus-100616299","NCT07303803","A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus","Chiglitazar in Combination With Anti-Inflammatory and Hepatoprotective Therapy for the Treatment in MASH Associated With T2DM: a Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Study","CHIG-MASH","Inclusion Criteria:\n\n1. Men and women aged at least 18 years and under 75 years (inclusive) at the time of obtaining consent.\n2. Participants must be diagnosed as T2DM and HbA1c ≤ 9.5% at time of screening.\n3. Participants must take Fibroscan examination with the result of CAP ≥ 238 dB\u002Fm and LSM\\>8.5 kPa.\n4. Diagnosis of MASH by liver biopsy, with NAFLD Activity Score (NAS) ≥4 with ≥1 point for each component, and fibrosis stage 1b or more over according to the NASH Clinical Research Network (CRN) scoring system. (or liver biopsy not more than 6 months prior to screening)\n5. Stable body weight (≤10% body weight change) for at least 3 months.\n6. Possess good understanding and behavior and be able to take the medication daily as required by the trial.\n7. Willing to sign the informed consent.\n\nExclusion Criteria:\n\n1. Alcohol consumption \\>20g ethyl alcohol\u002Fday for women and \\>40g ethyl alcohol\u002Fday for men.\n2. Evidence of other forms of chronic liver disease:\n\n   1. Alcoholic liver disease,\n   2. Hepatitis B as defined by presence of hepatitis B surface antigen (HBsAg) or hepatitis B DNA,\n   3. Hepatitis C as defined by presence of hepatitis C virus (HCV) RNA or positive hepatitis C antibody (anti-HCV),\n   4. Evidence of autoimmune liver disease as defined by compatible liver histology,\n   5. Current drug-induced liver disease as defined on the basis of typical exposure and history,\n   6. Suspected or proven liver cancer,\n   7. Any other type of liver disease other than MASH.\n3. Uncontrolled T2DM defined as HbA1c \\>9.5% at time of screening or Type 1 diabetes mellitus (T1DM).\n4. Patients with T2DM who have a history of diabetic ketoacidosis, proliferative diabetic retinopathy, diabetic maculopathy or severe non-proliferative diabetic retinopathy that requires acute treatment.\n5. Any of the following cardiovascular conditions within 6 months prior to screening:\n\n   1. acute myocardial infarction (MI),\n   2. cerebrovascular accident (stroke),\n   3. unstable angina,\n   4. hospitalization due to congestive heart failure (CHF)\n   5. New York Heart Association Functional Classification IV CHF\n6. History of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.\n7. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and\u002For diastolic blood pressure ≥ 100 mm Hg).\n8. Renal impairment measured as estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2.\n9. Known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect gastrointestinal motility.\n10. Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma (MTC).\n11. Evidence of untreated hypothyroidism or hyperthyroidism based on clinical or laboratory evaluation.\n12. A transplanted organ (corneal transplants allowed) or awaiting an organ transplant.\n13. Women of childbearing potential: positive pregnancy test during screening or at randomization or unwillingness to use an effective form of birth control during the trial (at least include one barrier contraceptive method) and breast feeding.\n14. Use of drugs associated with hepatic steatosis (e.g., amiodarone, methotrexate, tamoxifen) for more than 2 weeks in the 3 months prior to screening.\n15. Current use of medication is associated with weight gain, except when on stable dose for at least 3 months prior to screening and remaining on stable dose during the study.\n16. Receiving or having received (within 3 months of screening) chronic (\\>2 weeks) systemic glucocorticoid therapy.\n17. Use of treatment targeting MASH for more than 2 weeks in the 3 months prior to screening (GLP-1 receptor agonists or PPAR pan agonists).\n18. Any other condition which in the opinion of investigator would impede compliance or hinder completion of the study.","75 Years",{"count":76,"type":22},300,[78],"PHASE2","This trial aims to evaluate the efficacy and safety of chiglitazar as a combination therapy for patients with MASH and T2DM.",[81,28],"MASH - Metabolic Dysfunction-Associated Steatohepatitis",[83,84,85,86],"chiglitazar","metabolic dysfunction-associated steatohepatitis","type 2 diabetes","liver biopsy","2026-06-01",{"date":61,"type":35},{"date":90,"type":35},"2026-01-01",{"date":92,"type":22},"2030-12-01",{"name":94,"class":42},"Shanghai Jiao Tong University School of Medicine",17,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":106,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":43},"100638351","phase-3-to-evaluate-the-efficacy-and-safety-of-initial-combination-therapy-with-dwp16001-and-dwc202518-compared-to-dwp16001-monotherapy-and-dwc202518-monotherapy-in-patients-with-type-2-diabetes-mellitus-100638351","NCT07619833","To Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus","A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study to Evaluate the Efficacy and Safety of Initial Combination Therapy With DWP16001 and DWC202518 Compared to DWP16001 Monotherapy and DWC202518 Monotherapy in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n1. Able and willing to cooperate and participate in this clinical study after understanding the study explanation, and capable of voluntarily signing the written informed consent form before any assessments are performed.\n2. Male or female adult aged ≥18 and ≤80 years. Note: The minimum legal age of adult dependent on local regulations. The legal age of adult in Korea is 19 years, while in Indonesia, it is 18 years.\n3. Have been diagnosed with T2DM based on American Diabetes Association (ADA) guidelines (2025) before screening.\n4. Participants must meet one of the following conditions at Visit 1 (Screening):\n\n   * Have an HbA1c ≥7.5% and ≤11% at Visit 1 (Screening) and either have never taken oral anti-diabetic medication since diagnosis or have not taken any oral anti-diabetic medication within 12 weeks prior to screening.\n   * Have an HbA1c ≥6.5% and ≤10.5% at Visit 1 (Screening) and are currently taking one type of oral anti-diabetic medication at screening.\n\n   Note: The HbA1c level at Visit 1 can be measured by the local laboratory.\n5. Have an FPG \\\u003C15 mmol\u002FL (270 mg\u002FdL), as measured by local laboratory at Visit 1.\n6. Participants must meet all the following conditions at Visit 2 (Baseline):\n\n   * Have an HbA1c ≥7.5% and ≤11%, as measured by the central laboratory at Visit 1-1.\n   * Have an FPG \\\u003C15 mmol\u002FL (270 mg\u002FdL), as measured by central laboratory at Visit 1-1.\n7. Have a BMI ≥20 kg\u002Fm2 and ≤45 kg\u002Fm2 at screening.\n8. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening. WOCBP and their partners must use highly effective, medically accepted contraception to prevent pregnancy and must not have pregnancy or fertility plans throughout the study and for at least 4 weeks after the last dose of study medication\n9. Male participants must agree to use highly effective, medically accepted contraception and refrain from donating sperm throughout the study and for at least 4 weeks after the last dose of study medication\n\nExclusion Criteria:\n\n* Type 1 diabetes mellitus, congenital diabetes, secondary diabetes, or history of diabetic ketoacidosis, diabetic coma, or precoma\n* Severe diabetes-related complications, including proliferative diabetic retinopathy, advanced nephropathy, or severe diabetic neuropathy\n* Clinically significant renal disease, severe gastrointestinal disease or surgery affecting gastrointestinal absorption, pancreatitis, clinically significant urinary\u002Fgenital infections, dehydration requiring treatment, or uncontrolled thyroid disease\n* Clinically significant cardiovascular or cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, stroke, clinically significant arrhythmia requiring treatment, or New York Heart Association (NYHA) class III-IV heart failure\n* Active or untreated malignancy, or clinically significant malignancy within the previous 5 years (except adequately treated localized skin cancers or in situ carcinomas)\n* Hematologic conditions that may interfere with HbA1c measurement\n* Clinically significant endocrine disorders affecting glucose metabolism\n* Known or suspected hypersensitivity to study treatment or related products\n* Screening laboratory abnormalities including:\n\nㆍ Fasting C-peptide ≤0.60 ng\u002FmL ㆍ Triglycerides \\>500 mg\u002FdL ㆍ eGFR \\\u003C60 mL\u002Fmin\u002F1.73m² ㆍ AST or ALT ≥3× upper limit of normal (ULN), or total bilirubin ≥2× ULN\n\n* Positive hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection meeting protocol-defined criteria\n* Uncontrolled hypertension (systolic blood pressure \\>180 mmHg and\u002For diastolic blood pressure \\>110 mmHg)\n* Prior use of prohibited antidiabetic therapies, including prior antidiabetic combination therapy, thiazolidinediones within 12 weeks, or GLP-1 receptor agonists or insulin within 6 months before screening\n* Use of weight-loss medications within 3 months prior to screening or between screening and baseline\n* Use of systemic corticosteroids at pharmacologic doses within 1 month prior to screening or between screening and baseline","80 Years",{"count":105,"type":22},510,[107],"PHASE3","This study aims to evaluate the efficacy and safety of initial combination therapy with DWP16001 and DWC202518 compared to DWP16001 monotherapy and DWC202518 monotherapy in patients with Type 2 Diabetes Mellitus",[28],"2026-05-26",{"date":112,"type":35},"2026-06-02",{"date":114,"type":22},"2026-06",{"date":116,"type":22},"2027-11",{"name":118,"class":119},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":128,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":131,"conditions":132,"keywords":139,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100593355","fitbit-and-ai-chatbot-in-sedentary-primary-care-patients-with-t2d-100593355","NCT07005362","Fitbit and AI Chatbot in Sedentary Primary Care Patients With T2D","Feasibility of Use of Fitbit, Brief DSMES, and Targeted Text Messaging in Sedentary Adults With Type 2 Diabetes in Primary Care Settings","FIT T2D","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes per investigator discretion\n* No more than 20% of the sample will have A1c \\\u003C 7.5% (confirmed by medical record review or an A1c completed within 3 months of the screening visit)\n* Age ≥18 years and ≤ 80 years\n* Does not meet ADA guidelines for physical activity (\\\u003C 150 minutes of aerobic exercise per week defined as any activity where the participant can talk but not sing)\n* Has a smartphone compatible with a Fitbit\n\nExclusion Criteria:\n\n* Completing more than 60 minutes of moderate to vigorous activity per week defined as activity where you cannot sing (moderate) or can't say more than a few words without gasping for breath (vigorous)(14)\n* Any medical condition which, in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and\u002For eating disorders.\n* Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the previous 12- months\n* Any planned surgery during the study which could be considered major in the opinion of the investigator\n* Blood disorder or dyscrasia within 3 months before screening, or the use of hydroxyurea, which, in the investigator's opinion, could interfere with the determination of HbA1c\n* Has taken oral or injectable steroids within the past 8 weeks or plans to take oral or injectable steroids during the study, as they may interfere with the determination of HbA1c.\n* Planning to move from Colorado within 3 months\n* Current Pregnancy or planning on pregnancy in the next 3 months\n* Unable to safely comply with study procedures and reporting requirements (e.g. impairment of vision that impacts ability to see FitBit, impaired memory)\n* Unable to speak English as this is a small feasibility study that does not have the resources to adapt the intervention for Spanish\n* Current participation in another diabetes-related clinical trial",{"count":129,"type":22},36,"OBSERVATIONAL","The goal of this observational study is to evaluate the feasibility and acceptability of a 12-week intervention utilizing a Fitbit and artificial intelligence (AI)-delivered diabetes self-management education and support (DSMES) with tailored text messages.\n\nThe main question it aims to answer is:\n\nDoes providing a wearable fitness and activity tracker plus AI-tailored and DSMES improve clinical outcomes for patients with type 2 diabetes?\n\nParticipants will complete a baseline visit, wear a Fitbit and answer text messages for 12-weeks, and complete by a final visit.",[133,134,28,135,136,137,138],"Type 2 Diabetes","Type 2 Diabetes Mellitus (T2DM)","T2D","T2DM","Remote Patient Monitoring","Artificial Intelegence",[85,140,141,142,143,144],"artificial intelligence","fitbit","primary care","remote patient monitoring","physical activity","2026-05-15",{"date":147,"type":35},"2026-05-19",{"date":149,"type":35},"2025-09-03",{"date":151,"type":22},"2026-08-30",{"name":153,"class":42},"University of Colorado, Denver",{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":161,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":4},"100638530","chiglitazar-added-to-sglt-2-inhibitors-for-type-2-diabetes-100638530","NCT07580638","Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes","Chiglitazar Add-On to SGLT-2 Inhibitors in Patients With Type 2 Diabetes: A Nationwide, Multicenter Registry Study (C-STAR)","Inclusion Criteria:\n\n* Age between 18 and 75 years, inclusive.\n* Diagnosis of Type 2 Diabetes Mellitus (T2DM) .\n* Receiving stable-dose SGLT-2 inhibitor monotherapy or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%.\n* Must be willing to participate and have provided written informed consent.\n\nExclusion Criteria:\n\n* Current or routine use of insulin therapy.\n* Use of three or more antidiabetic drugs within one month prior to screening.\n* Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA).\n* Prior treatment with Chiglitazar Sodium.\n* Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C).\n* Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \\> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².",{"count":162,"type":22},3550,"The goal of this observational study is to evaluate the comprehensive clinical efficacy, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are:\n\nWhat is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control? What are the effects of this combination therapy on cardiovascular, renal, and hepatic outcomes? What is the overall safety of this treatment regimen?\n\nThis is a non-interventional study. Participants will be prescribed Chiglitazar or other oral antidiabetic drugs by their treating physician as part of their routine clinical care. For the purpose of this registry study, data will be collected from their regular medical follow-ups. Participants will:\n\nAttend regular follow-up visits as part of their standard diabetes care. Have data collected from their routine clinical assessments.",[28],"2026-05-05",{"date":167,"type":35},"2026-05-12",{"date":169,"type":22},"2026-07-18",{"date":171,"type":22},"2028-07-18",{"name":173,"class":119},"Chipscreen Biosciences, Ltd.",{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":23,"phases":183,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":4},"100634238","phase-4-efficacy-and-safety-of-triple-therapy-with-dulaglutide-sglt2-inhibitors-and-finerenone-in-chinese-adults-with-type-2-diabetes-and-chronic-kidney-disease-100634238","NCT07537088","Efficacy and Safety of Triple Therapy With Dulaglutide, SGLT2 Inhibitors, and Finerenone in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease","Efficacy and Safety of Dulaglutide, SGLT-2 Inhibitors, and Finerenone Triple Therapy in Chinese Adults With Type 2 Diabetes and Chronic Kidney Disease: A Multicenter, Prospective, Randomized Controlled Study","Inclusion Criteria:\n\n* 1.Patients aged ≥18 years with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD)\n* 2.Hemoglobin A1c (HbA1c) 7.0%-11%\n* 3.Urine albumin-to-creatinine ratio (UACR) 300-5000 mg\u002Fg\n* 4.Body mass index (BMI) 21-45 kg\u002Fm²\n* 5.Having received combination therapy with SGLT2 inhibitor and finerenone for 3 months or longer, on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi)\n* 6.Sign the informed consent, understand the procedures and methods of this trial and willing to strictly comply with the clinical trial protocol\n\nExclusion Criteria:\n\n* 1.Pregnant or lactating women, or women of childbearing potential unwilling to use reliable contraception\n* 2.History of definite contraindications or intolerance to glucagon-like peptide-1 receptor agonists (GLP-1RA), SGLT2 inhibitors, or finerenone\n* 3.Type 1 diabetes\n* 4.History of diabetic ketoacidosis (DKA) within the past 6 months\n* 5.Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²\n* 6.Hospitalization within 30 days prior to screening for acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction, or unstable angina), percutaneous coronary intervention, or cardiac surgery\n* 7.Uncontrolled hypertension, defined as systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg (mean of three supine measurements) during screening\n* 8.Symptomatic hypotension and\u002For systolic blood pressure \\\u003C90 mmHg at screening, or patients judged by the investigator to have hypovolemia\n* 9.Serum potassium \\>5.0 mmol\u002FL at screening\n* 10.Current use or use within 3 months prior to screening of GLP-1 receptor agonists or other mineralocorticoid receptor antagonists (e.g., spironolactone)\n* 11.Patients receiving or with clear clinical indications requiring systemic immunosuppressive therapy (including but not limited to prednisone, cyclosporine, etc.) for other kidney diseases (e.g., primary or secondary glomerulonephritis, lupus nephritis)\n* 12.History of recurrent urinary tract or genital infections (as judged by the investigator)\n* 13.Life expectancy \\\u003C1 year at screening\n* 14.Confirmed malignancy\n* 15.Participation in another clinical trial within 3 months prior to screening\n* 16.Any other condition judged by the investigator as unsuitable for participation in this clinical trial.",{"count":182,"type":22},468,[184],"PHASE4","The purpose of this study is to evaluate whether adding dulaglutide to the combination therapy of Sodium-Glucose Co-Transporter 2 Inhibitors(SGLT2i) and finerenone can provide additional kidney protection and safety for Chinese adults with Type 2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease(CKD). Eligible participants will be adults with T2DM and mild-to-moderate CKD who have been receiving SGLT2 inhibitor plus finerenone for at least 3 months on the basis of maximum tolerated dose of renin-angiotensin system inhibitor (RASi). Participants will be randomly assigned to either continue the original regimen or to receive add-on therapy with dulaglutide.The study will last for 26 weeks, with participants required to attend scheduled visits for efficacy and safety assessments at Week 13 (±1 week) and Week 26 (±1 week, final visit).",[28,187],"CKD - Chronic Kidney Disease","2026-04-17",{"date":190,"type":35},"2026-04-22",{"date":192,"type":22},"2026-05",{"date":194,"type":22},"2027-07",{"name":196,"class":42},"First Affiliated Hospital of Wannan Medical College",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":204,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":4},"100632867","bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100632867","NCT07519265","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg at screening;\n* A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",true,"45 Years",{"count":207,"type":22},64,[25],"This is a single-center, randomized, open-label, two-period, two-sequence crossover bioequivalence study under fed conditions. The primary objective is to evaluate the bioequivalence of a single oral dose of the test formulation compared with the reference formulation in the fed state.",[28],"2026-04-07",{"date":213,"type":35},"2026-04-09",{"date":215,"type":22},"2026-07-09",{"date":217,"type":22},"2026-08-10",{"name":173,"class":119},{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":204,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":226,"targetDuration":4,"studyType":23,"phases":228,"briefSummary":230,"conditions":231,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100632232","phase-1-food-effect-and-multiple-dose-study-of-chiglitazarmetformin-extended-release-tablets-100632232","NCT07511010","Food Effect and Multiple-Dose Study of Chiglitazar\u002FMetformin Extended-Release Tablets","A Phase I Clinical Study to Assess the Food Effect and Multiple Dose Pharmacokinetic of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 50 mmHg or ≥ 90 mmHg at screening;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",{"count":227,"type":22},28,[229],"PHASE1","This trial includes two parts: a food effect (FE) study and a multiple-dose pharmacokinetic (PK) study.\n\nThe FE study is a randomized, open-label, two-period, two-sequence crossover study designed to evaluate the effect of a high-fat meal on the PK of a single oral dose of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants.\n\nThe multiple-dose PK study is an open-label study designed to evaluate the PK characteristics of Chiglitazar\u002FMetformin extended-release tablets in healthy adult Chinese participants following multiple oral doses.",[28],"2026-04-01",{"date":234,"type":35},"2026-04-06",{"date":236,"type":22},"2026-10-08",{"date":238,"type":22},"2026-10-26",{"name":173,"class":119},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":246,"targetDuration":4,"studyType":130,"phases":4,"briefSummary":247,"conditions":248,"keywords":249,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100626865","efficacy-and-safety-of-henagliflozin-retagliptin-and-metformin-extended-release-tablets-in-chinese-patients-with-type-2-diabetes-mellitus-100626865","NCT07441187","Efficacy and Safety of Henagliflozin, Retagliptin, and Metformin Extended-Release Tablets in Chinese Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n1. Male or female aged 18 to 70 years (inclusive) at the time of signing the informed consent form.\n2. Diagnosed with type 2 diabetes mellitus.\n3. Voluntarily participate in this study and sign the informed consent form. If a subject is unable to read the informed consent form (e.g., an illiterate subject), an impartial witness must be present during the entire informed consent discussion and must also sign the consent form.\n4. At screening, the subject must meet either of the following two criteria:\n\n   1. Newly diagnosed with type 2 diabetes within 90 days prior to screening, with no prior use of any antidiabetic medication, and a screening HbA1c level between 8.0% and 11.0% (inclusive).\n   2. Treated with any one oral antidiabetic drug \\[metformin (with a stable daily dose ≥1000 mg or the maximum tolerated dose documented in the patient's medical record), an alpha-glucosidase inhibitor, a sulfonylurea, a glinide, a thiazolidinedione, a sodium-glucose cotransporter-2 inhibitor (SGLT2i), a dipeptidyl peptidase-4 inhibitor (DPP-4i), a glucokinase activator, or an oral glucagon-like peptide-1 receptor agonist\\] for at least 60 days prior to screening, with a screening HbA1c level between 7.0% and 11.0% (inclusive). The subject should have been on a stable dose of the medication for at least 30 days prior to screening.\n5. Body Mass Index (BMI) \\>19 kg\u002Fm² and ≤40.0 kg\u002Fm².\n\nExclusion Criteria\n\n1. Type 1 diabetes mellitus, monogenic diabetes, diabetes due to pancreatic injury, or other forms of secondary diabetes (e.g., diabetes secondary to Cushing's syndrome or acromegaly).\n2. Fasting C-peptide \\\u003C1.0 ng\u002FmL (0.34 nmol\u002FL) as measured by the local laboratory.\n3. Known or suspected hypersensitivity to the investigational product or related compounds.\n4. Participation in any other investigational drug trial within 3 months prior to the start of this study.\n5. Use of traditional Chinese herbal medicine for glycemic control within 2 months prior to screening (except for cumulative use ≤7 days).\n6. History of acute metabolic complications (e.g., ketoacidosis, lactic acidosis, hyperosmolar coma\u002Fstate) within the past 6 months.\n7. History of decompensated heart failure (NYHA Class IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, or cardiac surgery or vascular reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) within the past 6 months.\n8. Severe infection, significant trauma, or major surgery within 30 days prior to screening.\n9. History of acute or chronic pancreatitis.\n10. Patients with malignancy and a life expectancy of less than one year, active tuberculosis, or acute infection.\n11. Current or history of recurrent urinary tract infections and\u002For genital infections.\n12. Patients with a history of hypertension whose blood pressure remains uncontrolled despite antihypertensive medication: systolic blood pressure (SBP) \\>180 mmHg and\u002For diastolic blood pressure (DBP) \\>110 mmHg.\n13. Systolic blood pressure \\\u003C90 mmHg at the screening visit, or patients judged by the clinician to be hypovolemic.\n14. Moderate to severe renal impairment (eGFR \\\u003C45 mL\u002Fmin\u002F1.73m²), end-stage renal disease, or patients on dialysis.\n15. Men or women of childbearing potential unwilling to use effective contraception during the trial, or women who are pregnant or breastfeeding.\n16. Alanine aminotransferase (ALT) \\>3.0 x ULN and\u002For aspartate aminotransferase (AST) \\>3.0 x ULN and\u002For total bilirubin \\>2.0 x ULN (upper limit of normal).\n17. Any other condition that, in the investigator's judgment, renders the patient unsuitable for participation in this clinical trial.",{"count":76,"type":22},"Given the significant and growing burden of Type 2 Diabetes (T2DM) in China, there is a continuous need for effective, convenient, and well-tolerated treatment strategies. This Phase IV, multicenter, prospective, observational study aims to evaluate the real-world effectiveness and safety of a novel, once-daily, fixed-dose combination (FDC) tablet containing Henagliflozin (SGLT2 inhibitor), Retagliptin (DPP-4 inhibitor), and Metformin Extended-Release in Chinese patients with T2DM. The study plans to enroll approximately 300 patients across 30 sites, stratified into two cohorts: newly diagnosed, drug-naïve patients and those with inadequate glycemic control on a single prior oral antidiabetic drug. The primary objective is to assess the change in Glycated Hemoglobin (HbA1c) from baseline after 24 weeks of treatment. Key secondary objectives include evaluating the proportion of patients achieving HbA1c targets (\\\u003C7.0% and ≤6.5%), assessing changes in other metabolic parameters such as body weight, blood pressure, fasting and postprandial glucose, and lipid profiles, and monitoring treatment adherence. The safety evaluation will comprehensively document all adverse events, with special attention to events of interest including hypoglycemia, urinary\u002Fgenital infections, volume-related events, and diabetic ketoacidosis. The study design includes a screening period, a 2-week run-in with lifestyle intervention, a 24-week core treatment period where eligible patients receive the FDC therapy, and a final safety follow-up. Efficacy and safety assessments are scheduled at baseline, Week 4, Week 12, and Week 24. Statistical analysis will be primarily descriptive, focusing on changes from baseline for continuous endpoints and frequency distributions for categorical endpoints, with analyses conducted separately for the two patient cohorts. The study will be conducted in full compliance with Good Clinical Practice (GCP), the Declaration of Helsinki, and relevant Chinese regulations, requiring prior ethics committee approval and written informed consent from all participants. This real-world evidence study seeks to confirm the clinical benefits and safety profile of this triple-combination therapy observed in earlier controlled trials, providing practical insights into its use in routine management of T2DM within the Chinese healthcare context.",[28],[250],"SGLT2 inhibitor","2026-02-23",{"date":253,"type":35},"2026-02-27",{"date":255,"type":22},"2026-02-20",{"date":257,"type":22},"2027-12-31",{"name":259,"class":42},"Xinhua Hospital, Shanghai Jiao Tong University School of Medicine",{"id":261,"slug":262,"hasResults":11,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":204,"sex":17,"minAge":18,"maxAge":205,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":4},"100624621","pilot-bioequivalence-study-of-chiglitazarmetformin-extended-release-tablets-100624621","NCT07412015","Pilot Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Tablets","Pilot Bioequivalence Study of Chiglitazar\u002FMetformin Extended-Release Fixed Dose Combination Tablets in Healthy Subjects: A Randomized, Open-Label, Two-Period, Single-dose, Crossover Trial Under Fed Conditions","Inclusion Criteria:\n\n* Healthy male or female participants；\n* Age from 18 to 45 years, inclusive；\n* Body Mass Index (BMI) between 19.0 and 26.0 kg\u002Fm² (inclusive). Male participants must weigh at least 50.0 kg, and female participants must weigh at least 45.0 kg；\n* From the time of signing the informed consent form until 3 months after the last dose, participants must have no plans for pregnancy or sperm donation and must be willing to use effective contraceptive measures；\n* Voluntarily agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* Any clinically significant abnormalities in laboratory tests or a history of clinically significant diseases, including but not limited to cardiovascular, cerebrovascular, hepatic, renal, respiratory, gastrointestinal, neurological, hematological, immune, oncological, psychiatric, or endocrine\u002Fmetabolic disorders;\n* Known history of severe allergies (e.g., allergy to more than 3 allergens, allergies affecting the lower respiratory tract such as allergic asthma, allergies requiring glucocorticoid treatment) or a known history of allergy to any component of the investigational products;\n* Previous surgery that could affect drug absorption, distribution, metabolism, or excretion (e.g., subtotal gastrectomy), or a history of gastrointestinal, hepatic, or renal disease within the last 6 months that could affect drug absorption or metabolism;\n* Surgery within 3 months prior to screening or planned surgery during the study period;\n* Received any vaccination within 1 month prior to screening or plan to receive any vaccination during the study period;\n* History of infectious disease treated with significant use of antibiotics within 3 months before the first dose, or any infectious disease within 7 days before the first dose;\n* Presence of gastrointestinal symptoms (e.g., diarrhea, constipation, nausea, vomiting) within 7 days before the first dose, which the investigator deems unsuitable for study participation;\n* Use of any prescription drugs, over-the-counter drugs, or Chinese herbal medicines within 1 month before the first dose; or use of vitamin products within 2 weeks before enrollment;\n* History of drug or substance abuse, or a positive alcohol or urine drug screening test;\n* Intolerance to venipuncture, or a history of fainting in response to needles or blood;\n* Fasting blood glucose \\> 6.1 mmol\u002FL or \\\u003C 3.9 mmol\u002FL at screening, and\u002For a history of hypoglycemia\u002Fsyncope;\n* Participation in any interventional clinical trial within 3 months prior to screening;\n* Blood donation or significant blood loss (\\> 200 mL) within 3 months prior to screening;\n* Pregnant or lactating women;\n* Weekly alcohol consumption of more than 14 units within 3 months prior to screening, consumption of alcohol within 48 hours before the first dose, or inability to abstain from alcohol during the study;\n* Smokes more than 5 cigarettes per day within 3 months prior to screening, has smoked within 48 hours before the first dose, or is unable to abstain from smoking during the study;\n* Excessive daily consumption of tea, coffee, and\u002For caffeinated beverages within 3 months prior to screening, or consumption of such beverages within 48 hours before the first dose;\n* Consumption of grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos), star fruit, papaya, pomegranate, or their products within 14 days before the first dose;\n* Glomerular Filtration Rate (GFR) \\\u003C 90 mL\u002Fmin\u002F1.73 m²;\n* Systolic blood pressure \\\u003C 90 mmHg or ≥ 140 mmHg, or diastolic blood pressure \\\u003C 60 mmHg or ≥ 90 mmHg at screening;\n* A positive test result at screening for any of the following: Human Immunodeficiency Virus antibody, Treponema pallidum antibody, Hepatitis B surface antigen, or Hepatitis C virus antibody;\n* Inability to comply with the standardized diet (e.g., intolerance to the high-fat meal, lactose intolerance) or has difficulty swallowing;\n* Plans to or is required to engage in strenuous physical activity or exercise during the study period;\n* Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in the study.",{"count":268,"type":22},24,[25],"This is a pilot bioequivalence study. It is a randomized, open-label, single-dose, crossover study. The primary objective of this study is to preliminarily evaluate the pharmacokinetic parameters and their variability of the test formulation versus the reference formulation following a single oral dose under fed conditions.",[28],"2026-02-09",{"date":274,"type":35},"2026-02-17",{"date":276,"type":22},"2026-05-27",{"date":278,"type":22},"2026-06-29",{"name":173,"class":119},{"id":281,"slug":282,"hasResults":11,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":288,"enrollmentInfo":289,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100617135","phase-4-glp1-ras-effects-on-inflammatory-and-endothelial-biomarkers-in-t2dm-100617135","NCT07314684","GLP1-RAs Effects on Inflammatory and Endothelial Biomarkers in T2DM","Impact of GLP1-RAs on Inflammation and Endothelial biomarkerS in Type 2 diABetes meLlitus patiEnts: STABLE-GLP1 Trial","STABLE-GLP1","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Diagnosis of T2DM in patients without ASCVD or severe TOD but with SCORE2-Diabetes ≥10% with clinical indication in accordance with current guidelines \\[1\\] to initiate semaglutide therapy (level of evidence IIa).\n* Evaluable, pre-randomization CTA with no evidence of stenosis ≥50% of epicardial coronary vessels, as confirmed by the core laboratory, performed within 2 years prior to inclusion.\n* Stable clinical conditions, with controlled blood pressure, lipid profile, and glycemic values, based on assessments performed within 4 weeks prior to inclusion.\n* Stable antidiabetic treatment for at least 6 weeks.\n* Left ventricular ejection fraction ≥50%.\n* For female participants, the participant must not be pregnant or lactating and must be of non-childbearing potential, confirmed at enrollment by one of the following:\n\n  (a) Postmenopausal, defined as amenorrhea for ≥12 months following cessation of fall exogenous hormonal treatments, and with luteinizing hormone and follicle stimulating hormone levels in the postmenopausal range. (b) Documentation of irreversible surgical sterilization by hysterectomy bilateral oophorectomy, or bilateral salpingectomy. Tubal ligation is not considered as irreversible surgical sterilization.\n* Ability to understand study procedures and sign informed consent.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Age \\> 85 years.\n* Previous treatment with semaglutide or GLP1-RAs.\n* Patients with stenosis of epicardial coronary arteries ≥50%.\n* eGFR \\\u003C45 mL\u002Fmin\u002F1.73 m2 irrespective of albuminuria or eGFR 45-59 mL\u002Fmin\u002F1.73 m2 and microalbuminuria (UACR 30-300 mg\u002Fg; stage A2) or proteinuria (UACR \\>300 mg\u002Fg; stage A3) or presence of microvascular disease in at least three different sites \\[e.g. microalbuminuria (stage A2) plus retinopathy plus neuropathy\\], based on assessments performed within 4 weeks prior to inclusion.\n* History of any clinically important disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.\n* Any history of ASCVD.\n* Ongoing New York Heart Association Class IV (heart failure (HF).\n* Significant valvulopathy.\n* Type 1 diabetes mellitus.\n* Hypersensitivity to the active substance or to any of the excipients.\n* Known or suspected liver disease, defined by serum transaminase and alkaline phosphatase levels 3 times the normal level.\n* Patients with acute inflammatory or infectious diseases during the 3 months prior to inclusion in the study.\n* Patients with chronic inflammatory, immune or infectious diseases.\n* Patients with a history of cancer within the past 5 years.\n* History of alcohol, drug or medication abuse.\n* Patients exposed to any other type of radiation, medical or professional.\n* Clinically relevant haematological disorders.\n* Decompensated metabolic disorders.\n* Abuse of alcohol or drugs in the previous 3 months.","85 Years",{"count":290,"type":22},80,[184],"Type II diabetes mellitus (T2DM) is a chronic disease associated with a very high risk of developing cardiovascular (CV) events, especially because of its long-term effects. Glucagon-like-peptide-1 receptor agonists (GLP1-RAs) are recommended in subjects suffering from T2DM with a history or at risk for CV disease; however there is a lack of evidence on local actions of GLP1-RAs on inflammation and endothelial function.\n\nThe STABLE-GLP1 study aims to evaluate, in patients with T2DM without atherosclerotic cardiovascular disease (ASCVD) or severe target-organ damage (TOD), the possible beneficial effect of semaglutide, a GLP1-AR, on clinical prognosis, inflammatory and endothelial biomarkers.\n\nThe STABLE-GLP1 trial is a phase IV interventional, national, multicenter, randomized, pragmatic study, aiming at enrolling 80 patients with T2DM and no ASCVD. Participants will be randomized in 1:1 ratio to receive semaglutide in addition to standard therapy or standard therapy alone, according to body mass index (BMI) category (BMI \\\u003C30 vs. ≥30 kg\u002Fm²). All patients will perform clinical visit, ECG, echocardiography, blood sample collection for endothelial and inflammatory biomarkers dosage at baseline, at 26 weeks, and after 52 weeks of treatment. Data from CTA, performed according to clinical practice before enrollment, will be recorded and retrospectively evaluated to test secondary outcomes.",[28],[295,296,297,298,299,300],"Type 2 Diabetes Mellitus","Semaglutide","Inflammation","Endothelial function","Biomarkers","Coronary Plaque","2025-12-17",{"date":303,"type":35},"2026-01-02",{"date":305,"type":35},"2025-09-08",{"date":307,"type":22},"2027-03-08",{"name":309,"class":42},"Federico II University",2,{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":319,"targetDuration":4,"studyType":23,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":43},"100611701","phase-4-efficacy-and-safety-of-the-metsglt-2iglp-1ra-in-patients-with-type-2-diabetes-with-poor-glycemic-control-100611701","NCT07244003","Efficacy and Safety of the Met+SGLT-2i+GLP-1RA in Patients With Type 2 Diabetes With Poor Glycemic Control","Efficacy and Safety of the Triple Combination Therapy of Met\u002FSGLT-2i\u002FGLP-1RA or Other Oral Antidiabetic Drugs in Patients With Type 2 Diabetes Exhibiting Poor Glycemic Control","MESSAGE","Inclusion Criteria:\n\n* Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female;\n* Body mass index (BMI) ≥20kg\u002Fm² ;\n* Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C \\>=7.5% and\\\u003C=11.0%);\n* Volunteer to participate in this study and sign informed consent.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes or other special types of diabetes;\n* Patients with acute complications of ketoacidosis\u002Fhyperglycemic hyperosmolar state\u002Flactic acidosis within 6 months before screening\n* Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy\n* Those who received insulin treatment within the previous week\n* Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides \\> 5.7 mmol\u002FL during the screening period\n* Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 UNL, or total blood bilirubin (TBIL) \\> 2 UNL;\n* Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL\u002Fmin\u002F1.73m² or serum creatinine≥1.5 UNL;\n* Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2)\n* Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period\n* Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs;\n* Those who have participated in other drug clinical trials within 3 months before screening; 21. Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.",{"count":320,"type":22},430,[184],"The main objective of this study is to compare the efficacy and safety of the triple combination therapy of Met\u002FSGLT-2i\u002FGLP-1RA or other oral antidiabetic drugs in patients with type 2 diabetes exhibiting poor glycemic control.",[28],"2025-11-21",{"date":326,"type":35},"2025-11-24",{"date":328,"type":35},"2025-03-29",{"date":330,"type":22},"2028-06-30",{"name":332,"class":119},"Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":339,"eligibilityCriteria":340,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":341,"targetDuration":4,"studyType":23,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":346,"lastUpdatePostDateStruct":347,"startDateStruct":349,"completionDateStruct":351,"leadSponsor":353,"locationsCount":43},"100601932","phase-4-ganagliflozin-on-the-progression-of-kidney-disease-in-subjects-with-type-2-diabetes-mellitus-and-chronic-kidney-disease-100601932","NCT07116928","Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease","A Randomized, Double-blind, Placebo-controlled, Multicenter Study of the Effects of Ganagliflozin on the Progression of Kidney Disease in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease","GLOW-CKD","Inclusion Criteria:\n\n* Male or female individuals aged 18 years and above;\n* Meets the diagnostic criteria for T2DM;\n* Meets the diagnostic criteria for CKD, during the screening period（CKD-EPI Formula）: eGFR ≥ 30 to \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2, and UACR is ≥ 30 to \\\u003C 5000 mg\u002Fg; Or eGFR ≥ 60 to \\\u003C 90 mL\u002Fmin\u002F1.73m\\^2, and UACR is ≥ 300 to \\\u003C 5000 mg\u002Fg ;\n* HbA1c ≥ 6.5% to ≤ 12%;\n* If there are no contraindications or special instructions, all subjects must take a stable dose of ACEi or ARB at least 4 weeks before randomization;\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes or other special types of diabetes;\n* A medical history or clinical evidence indicating that the subjects have other primary kidney diseases and secondary kidney diseases other than type 2 diabetes (including but not limited to lupus nephritis, ANCA-related nephritis);\n* History of kidney transplantation;\n* Blood potassium level \\> 5.5 mmol\u002FL during the screening period.\n* New York Heart Association (NYHA) classification of grade IV during the screening period;\n* Experienced ketoacidosis, myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), hospitalization due to heart failure, or hospitalization due to urinary tract infection or acute kidney injury within 12 weeks before the screening period;\n* Receiving ACEi and ARB in combination;\n* Receiving mineralocorticoid receptor antagonists (MRA) or direct renin inhibitors (DRI) within 8 weeks before randomization;\n* Receiving drugs with immunosuppressive effects (such as cyclophosphamide, cyclosporine A, tacrolimus, etc.) or biological agents (rituximab, belimumab, etc.) during the 12 weeks before the screening period;\n* Receiving SGLT-2 inhibitors or GLP-1 receptor agonists within 8 weeks before the screening, or have previously used SGLT-2 inhibitor drugs and discontinued due to poor efficacy.",{"count":342,"type":22},1244,[184],"This study aims to investigate the impact of adding Ganagliflozin tablets to the current background therapy on preventing the progression of kidney disease in subjects with type 2 diabetes and chronic kidney disease. The efficacy and safety will be evaluated by comparing the effects of Ganagliflozin tablets and placebo tablets added to the current background treatment over 120 weeks",[28,187],"2025-11-16",{"date":348,"type":35},"2025-11-18",{"date":350,"type":22},"2025-11-30",{"date":352,"type":22},"2031-12-30",{"name":332,"class":119},{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":371,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":383,"locationsCount":43},"100604376","pilot-of-continuous-glucose-monitor-augmented-food-is-medicine-100604376","NCT07148713","Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine","Pilot of a CGM-Augmented Food Is Medicine Intervention","ALIGN","Inclusion Criteria:\n\n* Able to complete study activities in English\n* Aged ≥18 years\n* Type 2 diabetes as defined by self-report and confirmed by ICD-10 codes\n\n  * Chart review will be conducted by the study team and a diagnosis of type 2 diabetes (E.11.xx) from either the problem list or a diagnosis linked to an encounter will be used as confirmation. Discrepancies in diagnosis codes will be resolved by review of provider notes within the past 3 years.\n* HbA1c \\> 8.0% in the last 12 months via point of care or venous measurement. If there are multiple values, the most recent one will be considered.\n* Receiving primary or specialty care within UNC Health as defined by at least one visit with a primary care provider or endocrine provider within the past year\n* Indication of a barrier to healthy eating consisting of report of food insecurity (defined as a score greater or equal to 1.0 on the 6-item USDA Food Security Survey Module (FSSM)) and\u002FOR nutrition insecurity (defined as more often than 'Rarely' on the One-Item Gretchen Swanson Nutrition Screener, OR more often than 'Not Very Hard' on the Two-item Nutrition Security Screener (NSS))\n\n  * Any positive screen on the FSSM, Gretchen Swanson Nutrition Screener, or NSS\n* No plans to move from the area for at least 4 months\n* Willing and able to provide written informed consent and participate in all study activities\n\nExclusion Criteria:\n\n* Type 1 or other diabetes\n* Use of insulin or secretagogues in the preceding 6 months\n* Use of CGM in the preceding 6 months\n* Inability to use CGM and related technology (e.g., the companion app), including lack of a smartphone that is compatible with Stelo (information on compatible phones available in Appendix 1) or known allergy to adhesive\n* Known psychosis or major psychiatric illness that prevents participation with study activities\n* Pregnancy or planned pregnancy in the next 4 months-glycemic targets are different for pregnant women compared to non-pregnant women with diabetes and our intervention is designed for non-pregnant glycemic targets\n* Participant in diabetes, nutrition, or weight research intervention in last 12 months",{"count":363,"type":22},60,[25],"This study is designed to test the feasibility and preliminary efficacy of a continuous glucose monitor (CGM)-augmented food is medicine (FIM) intervention for adults with type 2 diabetes and nutrition or food insecurity. This study will learn if a FIM intervention (\"intervention\") that includes access to real-time CGM and nutrition counseling can increase engagement, improve glycemic management, and support healthy eating in this population, compared to the FIM intervention alone (\"comparator\").\n\nAt the study baseline, participants will be randomized to either the intervention or the comparator arm for 16 weeks. The intervention will occur during the first 12 weeks (phase 1: intervention phase) and will be compared to a standard FIM approach without CGM or counseling. Phase 2 (extension phase) will last 4 weeks and will consist of all participants in the intervention and comparator arm receiving both FIM and CGM for self-directed use. The study will also explore participant experiences through a series of semi-structured interviews with a subset of randomly selected participants to identify opportunities for scaling the intervention to a broader population.",[367,133,136,28,368,369,370],"Nutrition","Diabetes Education","Diabetes Type 2","Diabetes Mellitis",[372,136,367,373,374,133,375,376],"Diabetes","Food is Medicine","Continuous glucose monitor","Food insecurity","Nutrition insecurity","2025-11-10",{"date":379,"type":35},"2025-11-12",{"date":381,"type":35},"2025-09-19",{"date":114,"type":22},{"name":384,"class":42},"University of North Carolina, Chapel Hill",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":392,"targetDuration":4,"studyType":23,"phases":394,"briefSummary":395,"conditions":396,"keywords":398,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":412},"100361527","comparing-the-efficacy-and-safety-between-continuous-subcutaneous-beinaglutide-and-csii-for-newly-diagnosed-t2dm-patients-100361527","NCT03987308","Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients","Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls","Inclusion Criteria:\n\n1. Age 18 to 70 years (inclusive) at enrollment, regardless of gender.\n2. Voluntary signing of the informed consent form.\n3. Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.\n4. HbA1c between 7.5% and 10.0%.\n5. BMI between 24 kg\u002Fm² and 42 kg\u002Fm².\n6. Subjects who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent form).\n7. Subjects with reproductive potential (including male subjects whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes or other types of diabetes.\n2. History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.\n3. History of pancreatitis.\n4. Family history of medullary thyroid carcinoma.\n5. History of malignant tumors.\n6. ALT, AST \\>3 times the upper limit of normal, and\u002For total bilirubin \\>2 times the upper limit of normal.\n7. Moderate to severe renal insufficiency (eGFR \\\u003C60 ml\u002Fmin\u002F1.73m²).\n8. Triglycerides ≥5.0 mmol\u002FL.\n9. Multiple endocrine neoplasia type 2 (MEN 2).\n10. Participation in any pre-marketing drug study within 3 months.\n11. Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.\n12. History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.\n13. Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥100 mmHg.\n14. History of any of the following cardiovascular diseases within 3 months prior to screening: acute myocardial infarction, New York Heart Association functional class III\u002FIV heart failure or left ventricular ejection fraction ≤40%, or cerebrovascular event (stroke).\n15. Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.\n16. Presence of other severe diseases that may interfere with the study, as judged by the investigator.\n17. Pregnant or breastfeeding women.\n18. Poor compliance, as judged by the investigator, and inability to complete the study as required.\n19. Inability to undergo continuous pump infusion: subjects allergic to subcutaneous infusion tubes or adhesive tape; subjects unwilling to have long-term subcutaneous infusion tubes or continuous pump use; subjects with psychological aversion to pump therapy; subjects or their families lack relevant knowledge and are unable to master the use after training; subjects with severe psychological disorders or mental abnormalities; subjects who are unable to care for themselves and have no caregivers.\n20. Any other factors deemed unsuitable for participation in the study by the investigator.",{"count":393,"type":22},115,[25],"The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.",[397,28,136],"Type 2 Diabetic Patients",[136,399,400,401],"beinaglutide","CSII","subcutaneous pump","2025-04-30",{"date":404,"type":35},"2025-05-02",{"date":406,"type":35},"2019-07-02",{"date":408,"type":22},"2025-12",{"name":410,"class":411},"Beijing Hospital","OTHER_GOV",16,{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":23,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":43},"100586235","group-emotion-focused-behavioral-intervention-for-diabetes-distressa1c-in-t2d-100586235","NCT06912737","Group Emotion-Focused Behavioral Intervention for Diabetes Distress\u002FA1c in T2D.","Development of a Group Emotion-Focused Behavioral Intervention for Diabetes Distress and Glycemic Management in Patients With T2D.","Inclusion Criteria:\n\n1. Male and female adults with documented diagnosis of T2D for at least one year.\n2. Age \\> 18 years of age.\n3. Diabetes Distress Scale score \\> 2.0 on any DDS subscale.\n4. A1c \\> 7.5 (with hemoglobin in the normal range).\n5. PHQ-9 Depression score \\\u003C 15.\n6. Stable medical co-morbid conditions.\n7. Absence of a psychotic disorder or an intellectual disability.\n8. Able to read English.\n9. Able to give informed consent.\n\nExclusion Criteria:\n\n1. Male and female adults with documented diagnosis of T2D for less than one year.\n2. Age \\\u003C 18 years of age.\n3. Diabetes Distress Scale score \\\u003C 2.0 on all DDS subscales.\n4. A1c \\\u003C 7.5 (with hemoglobin in the normal range).\n5. PHQ-9 Depression score \\> 15.\n6. Unstable medical co-morbid conditions (e.g., hospitalization in past three months).\n7. Presence of a psychotic disorder or an intellectual disability.\n8. Initiation of psychotherapy or pharmacotherapy for emotional issues within three months of study entry.\n9. Unable to read English.\n10. Unable to give informed consent.",{"count":421,"type":22},120,[25],"T2D is a major public health problem and is currently the 7th leading cause of death in the US. Despite a range of efficacious treatments, less than 50% of patients achieve a glycemic target of A1c \\\u003C 7.0%, suggesting that this is due to difficulty with following medical regimens to reduce A1C levels. While a range of factors have been identified in this regard, we posit that a barrier to treatment are broad difficulty with emotional regulation that are not diagnosis-specific but lead to Diabetes Distress (DD) and difficulty in coping with medical regimens, and other aspects of diabetes self-care, in the context of the psychosocial stressors associated with T2D. Extant data suggests that sub-optimal emotional regulation (experience of intense emotion and skill at regulating emotion) is related to elevated DD and A1c levels, and that an Emotion-Focused Behavioral Intervention (EFBI) can reduce both DD and A1c levels in PWD with T2D. In this project we seek to take our one-to-one intervention, now adapted to a group intervention (G-EFBI) and collect feasibility, acceptability, and preliminary efficacy data to determine if G-EFBI is a feasible, acceptable and, possibly, efficacious intervention compared to an \"Attentional Control\" intervention in PWD with T2D and elevated DD and A1c levels.",[28],[135,426,427],"Diabetes Distress","HbA1c","2025-04-02",{"date":430,"type":35},"2025-04-06",{"date":432,"type":22},"2025-09-01",{"date":434,"type":22},"2028-01-31",{"name":436,"class":42},"Ohio State University",{"id":438,"slug":439,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":443,"eligibilityCriteria":444,"healthyVolunteers":11,"sex":17,"minAge":445,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":23,"phases":448,"briefSummary":449,"conditions":450,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":452,"lastUpdatePostDateStruct":453,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":43},"100538636","to-assess-with-ezefeno-tab-in-patients-with-dyslipidemia-and-t2dm-100538636","NCT06293417","To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM","To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy","ENSEMBLE","Inclusion Criteria:\n\n* Patients with type 2 diabetes diagnosed by American Diabetes Association criteria\n* Age ≥ 19 years\n* Non-HDL-C ≥100 mg\u002FdL, TG ≥200, \\\u003C500 mg\u002FdL on moderate-intensity statins\n* with cardiovascular risk factor\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)\n* Patient with myopathy and rhabdomyolysis\n* AST\u002FALT more than 3 ULN\n* Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and\u002For glucose-galactose malabsorption","19 Years",{"count":447,"type":22},3958,[25],"The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are:\n\n* major adverse cardiovascular events within 48 months of the trial duration\n* microvascular events within 48 months of the trial duration",[28,451],"Dyslipidemias","2024-08-25",{"date":454,"type":35},"2024-08-27",{"date":456,"type":35},"2024-03-01",{"date":458,"type":22},"2027-02-01",{"name":460,"class":42},"Korea University Anam Hospital",{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":469,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":23,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":56,"whyStopped":4,"lastUpdateSubmitDate":476,"lastUpdatePostDateStruct":477,"startDateStruct":479,"completionDateStruct":481,"leadSponsor":483,"locationsCount":43},"100475340","phase-2-effect-of-tofogliflozin-on-uacr-compared-to-metformin-hydrochloride-in-diabetic-kidney-disease-truth-dkd-100475340","NCT05469659","Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD)","Effect of Tofogliflozin on Urine Albumin-to-Creatinine Ratio Compared to Metformin Hydrochloride in Diabetic Kidney Disease","TRUTH-DKD","Inclusion Criteria:\n\n* Type 2 diabetic patients\n* Patients aged 20 years or older at the time of obtaining consent\n* Patients with HbA1c 6.5 or more and 9.0% or less within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor \u002F metformin)\n* Patients who have been judged by their doctor to need a diabetic drug when they are first seen, or who have already taken a diabetic drug and have decided that it is necessary to add one diabetic drug.\n* Patients who have been receiving RAS inhibitors (ARB, ARNI, ACE inhibitors, direct renin inhibitors) for 4 weeks or longer\n* Patients with eGFR of 30 or more (mL \u002F min \u002F 1.73m2) within 13 weeks before obtaining consent (evaluated by test values after 4 weeks or more without taking SGLT2 inhibitor \u002F metformin)\n* Patients with urinary albumin \u002F creatinine ratio (UACR) of 30 or more and less than 2000 (mg \u002F gCr) (4 weeks or more without taking SGLT2 inhibitor \u002F metformin) within 13 weeks before obtaining consent Evaluate by inspection value)\n* Patients for whom written consent was obtained based on the patient's free will after receiving sufficient explanation for participation in this study\n\nExclusion Criteria:\n\n* Patients receiving treatment with SGLT2 inhibitor or metformin within 13 weeks before obtaining consent\n* Dialysis patient\n* Patients with a history of severe hypoglycemia\n* Patients with hypersensitivity to SGLT2 inhibitor or metformin\n* Pregnant women, lactating patients, and patients who wish to raise children\n* Patients with BMI of 35 kg \u002F m2 or more based on the latest measured values within 13 weeks before obtaining consent\n* Patients who are contraindicated for the study drug\n* Other patients who the attending physician deems inappropriate as a subject","20 Years",{"count":421,"type":22},[78],"This multicenter, randomized, open-label, controlled study will assess the efficacy of the SGLT2 inhibitor tofogliflozin on Urine Albumin-to-Creatinine Ratio (UACR) compared to metformin in patients with type 2 diabetes with chronic kidney disease (CKD).",[28,474,475],"Metformin","SGLT2-Inhibitors","2022-07-21",{"date":478,"type":35},"2022-07-22",{"date":480,"type":35},"2021-09-22",{"date":482,"type":22},"2026-10-30",{"name":484,"class":42},"Shinshu University"]