[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"t2dm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:t2dm":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,43,70,106,129,153,176,199,229,261,288,309,325,349,370,398,418],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100633512","phase-2-study-to-evaluate-hm15275-in-subjects-with-type-2-diabetes-mellitus-100633512",false,"NCT07527650","Study to Evaluate HM15275 in Subjects With Type 2 Diabetes Mellitus","A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate Efficacy, Safety, and Tolerability of HM15275 for 36 Weeks in Subjects With Type 2 Diabetes Mellitus","Key Inclusion Criteria\n\n1. Participant's age at the time of signing the informed consent:\n\n   * United States: 18 to 75 years (inclusive)\n2. Diagnosed with type 2 diabetes mellitus (T2DM) with HbA1c ≥7.0% and ≤10.0% at screening\n3. Treated with diet and exercise alone or on a stable dose of metformin (≥1000 mg\u002Fday) for at least 3 months prior to screening\n4. BMI ≥25 kg\u002Fm² and ≤50 kg\u002Fm²\n5. Body weight change \\\u003C5% over the past 3 months prior to screening\n6. Capable of giving signed informed consent and willing to comply with all protocol procedures\n\nKey Exclusion Criteria\n\n1. Type 1 diabetes mellitus or use of glucose-lowering medications other than metformin within 3 months prior to screening\n2. Poor glycemic control (fasting plasma glucose \\>270 mg\u002FdL)\n3. History of diabetic ketoacidosis or severe hypoglycemia within 6 months\n4. Clinically significant cardiovascular disease (e.g., NYHA class III\u002FIV heart failure, recent myocardial infarction, stroke, or revascularization within 3 months)\n5. History of pancreatitis or factors increasing the risk of pancreatitis\n6. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2\n7. Clinically significant liver disease, renal impairment (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²), or abnormal laboratory findings at screening\n8. Participation in another investigational study within 30 days or within 5 half-lives of the investigational product, whichever is longer; for GLP-1 receptor agonist-related or weight loss studies, participation within 3 months prior to screening","ALL","18 Years","75 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study is a Phase 2 clinical trial to evaluate the efficacy, safety, and tolerability of HM15275 in subjects with type 2 diabetes mellitus over 36 weeks.",[27,28],"Type 2 Diabetes Mellitus","T2DM",[27,28],"RECRUITING","2026-06-30",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2026-05-18",{"date":38,"type":21},"2027-10",{"name":40,"class":41},"Hanmi Pharmaceutical Company Limited","INDUSTRY",10,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100630385","endocrine-disruption-menopause-and-poor-sleep-in-women-with-type-2-diabetes-effects-on-cardiovascular-health-100630385","NCT07486986","Endocrine Disruption, Menopause, and Poor Sleep in wOmen With Type 2 Diabetes: Effects on Cardiovascular Health","EMPOWER","Inclusion Criteria:\n\n* Female Sex\n* Age range 48-58 years\n* In menopausal transition phase (pre-menopause or peri-menopause)\n* Diagnosis of Type 2 Diabetes Mellitus\n* Have access to and regularly use a smartphone with internet access\n\nExclusion Criteria:\n\n* Male Sex\n* Currently Pregnant\n* Prior history of total hysterectomy or bilateral oophorectomy\n* Prior diagnosis of any of the following:\n\nCoronary Vascular Disease (CVD) including coronary heart disease, heart failure, congenital heart disease stroke\u002Ftransient ischemic attack, valvular heart disease, peripheral vascular disease, aortapathy, atrial fibrillation or flutter, other CVD.\n\n\\- Untreated serious mental illness (e.g, untreated psychosis).","FEMALE","48 Years","58 Years",{"count":54,"type":21},381,"OBSERVATIONAL","EMPOWER aims to determine the overall effect of menopause and sleep disruption on cardiac remodeling in women with type 2 diabetes.",[58,59,28],"Menopause","Sleep Disruption","NOT_YET_RECRUITING",{"date":62,"type":34},"2026-07-01",{"date":64,"type":21},"2026-09",{"date":66,"type":21},"2032-12",{"name":68,"class":69},"Ottawa Heart Institute Research Corporation","OTHER",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"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","80 Years",{"count":80,"type":21},36,"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.",[83,84,85,86,28,87,88],"Type 2 Diabetes","Type 2 Diabetes Mellitus (T2DM)","T2DM (Type 2 Diabetes Mellitus)","T2D","Remote Patient Monitoring","Artificial Intelegence",[90,91,92,93,94,95],"type 2 diabetes","artificial intelligence","fitbit","primary care","remote patient monitoring","physical activity","2026-05-15",{"date":98,"type":34},"2026-05-19",{"date":100,"type":34},"2025-09-03",{"date":102,"type":21},"2026-08-30",{"name":104,"class":69},"University of Colorado, Denver",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100637463","phase-2-a-research-study-to-investigate-the-efficacy-and-safety-of-hrs9531-tablets-in-participants-with-type-2-diabetes-mellitus-100637463","NCT07599410","A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus","A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group Phase 2 Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus.","Inclusion Criteria:\n\n1. Male or female, aged 18 to 70 years on the day of signing the informed consent form;\n2. Have a documented history of type 2 diabetes mellitus for at least 6 months at screening, diagnosed according to the criteria in Guidelines for the Prevention and Treatment of Type 2 Diabetes in China (2024 Edition);\n3. HbA1c between 7.5% and 10.5% at screening;\n4. Have received lifestyle intervention alone for at least 8 weeks, or stable metformin monotherapy for at least 8 weeks prior to screening. Stable treatment is defined as no change in daily drug dosage, with no planned modifications to the regimen during the entire trial period;\n5. Fasting plasma glucose ≤ 15 mmol\u002FL;\n6. Body mass index (BMI) between 20.0 kg\u002Fm² and 40.0 kg\u002Fm² at screening;\n7. Voluntarily sign the informed consent form before the trial, fully understand the trial content, procedures and potential adverse reactions, and be able and willing to comply with protocol requirements to complete the study;\n8. Have no fertility plans from the signing of the informed consent form until 2 months after the last dose, and agree to use highly effective contraceptive measures as specified in the protocol.methods.\n\nExclusion Criteria:\n\n1. Participants with relevant abnormal test results at screening.\n2. Participants with clinically significant abnormal findings on electrocardiogram (ECG) that, in the investigator's opinion, may compromise subject safety.\n3. Participants with poorly controlled blood pressure.\n4. Participants diagnosed with or suspected of having type 1 diabetes, specific types of diabetes, or secondary diabetes.\n5. Participants who experienced acute diabetic complications within 6 months prior to screening.\n6. Participants who experienced severe hypoglycemic events or recurrent hypoglycemic events within 6 months prior to screening.\n7. Participants with severe chronic diabetic complications at screening, or non-proliferative diabetic retinopathy requiring treatment during the trial.\n8. Participants with a past or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2).\n9. Participants with a past or known history of acute or chronic pancreatitis, pancreatic injury, acute cholecystitis, or symptomatic\u002Ftreatment requiring gallbladder disease.\n10. Participants with a past history of significant gastrointestinal diseases (such as severe diabetic gastroparesis, gastric outlet obstruction, inflammatory bowel disease, active ulcer, etc.), or who have undergone gastrointestinal surgery (excluding gastrointestinal polypectomy and appendectomy), or who are taking long-term medications that directly affect gastrointestinal motility.\n11. Participants with a history of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening.\n12. Participants with known or suspected depression, bipolar disorder, suicidal ideation, schizophrenia, or other severe psychiatric disorders; or participants who are mentally incompetent, have language barriers, are unable to fully understand the trial protocol, or are unwilling to cooperate with study site staff.\n13. Participants with a history of malignant tumor within 5 years prior to screening, except for cured localized cancers such as localized basal cell carcinoma of the skin, cervical carcinoma in situ, and prostate carcinoma in situ.\n14. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the trial.\n15. Any other conditions that, in the investigator's judgment, render the subject unsuitable for participation in this clinical trial.","70 Years",{"count":115,"type":21},240,[24],"The aim of the trial is to investigate the efficacy and safety of HRS9531 tablets versus placebo in participants with type 2 diabetes mellitus who failed to achieve adequate glycemic control on lifestyle intervention alone or on a stable dose of metformin. This study will last 20 weeks.",[28],"2026-05-14",{"date":121,"type":34},"2026-05-20",{"date":123,"type":21},"2026-07",{"date":125,"type":21},"2027-07",{"name":127,"class":41},"Fujian Shengdi Pharmaceutical Co., Ltd.",2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":142,"conditions":143,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":105},"100619627","early-phase-1-a-single-center-open-label-single-ascending-dose-study-of-exenatide-circular-rna-lipid-nanoparticle-injection-cr059-in-chinese-subjects-with-type-2-diabetes-mellitus-100619627","NCT07347080","A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus","A Single-Center, Open-Label, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus","CR059101","Inclusion Criteria:\n\n* Chinese male or female， 18≤age≤-65 years .\n* Diagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's \"Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2024 Edition)\" diagnostic criteria.\n* Patients who have failed treatment with diet and exercise alone, or metformin monotherapy, or a stable regimen for 12 weeks of metformin (dose ≥1500 mg\u002Fday or maximum tolerated dose ≥1000 mg\u002Fday) combined with one of the following oral antidiabetic drugs (or their fixed-dose combinations): sulfonylureas, glinides, alpha-glucosidase inhibitors, SGLT2 inhibitors, or thiazolidinediones (at ≥1\u002F2 the maximum approved dose, or the recommended minimum maintenance dose for SGLT2 inhibitors e.g., empagliflozin 10mg, canagliflozin 100mg). Fasting Plasma Glucose (FPG) must be \\\u003C13.0 mmol\u002FL, and 7.5%≤HbA1c ≤ 10.0%.\n* 18.5 kg\u002Fm²≤Body Mass Index (BMI) ≤40.0 kg\u002Fm² at screening and enrollment\n* Subjects have no pregnancy plan from screening until 3 months after the last dose and are willing to use at least one effective method of contraception during the entire trial period until 3 months after the last dose.\n* Able to understand and willing to sign the informed consent form, and fully understand the trial content, procedures, and potential adverse reactions.\n* Able to complete the trial according to the protocol requirements.\n\nExclusion Criteria:\n\n* Diagnosis of type 1 diabetes, diabetes due to pancreatic injury, or specific types of diabetes due to other diseases (e.g., acromegaly or Cushing's syndrome).\n* History of acute diabetic complications, such as ketoacidosis or hyperosmolar coma, within 6 months before screening.\n* Presence of severe chronic diabetic complications (e.g., proliferative diabetic retinopathy, severe diabetic neuropathy, diabetic foot, etc.) within 6 months before screening, deemed by the investigator as unsuitable for participation.\n* Allergic constitution (allergy to ≥2 types of drugs or foods) or keloid tendency, or clear history of drug allergy, or investigator suspects potential allergy to the investigational product or its components or similar drugs.\n* Fasting plasma glucose \\\u003C3.9 mmol\u002FL at screening or before enrollment, and\u002For history of ≥2 episodes of severe hypoglycemia or recurrent symptomatic hypoglycemia within 6 months before screening.\n* History or presence of Cushing's syndrome, polycystic ovary syndrome, or other hereditary endocrine diseases, or obesity secondary to factors such as hormones.\n* Use of weight-control medications or weight-loss surgery within 3 months before screening, or weight fluctuation exceeding 5% within 3 months.\n* Clinically significant abnormal TSH, FT3, or FT4 at screening, or previous diagnosis of thyroid dysfunction, deemed unsuitable by the investigator.\n* Personal or family history of multiple endocrine neoplasia type 2; personal or family history of medullary thyroid carcinoma; or thyroid nodules classified as C-TIRADS category 4 or higher on ultrasound.\n* History or presence of malignant tumors (except cured basal cell carcinoma or cervical carcinoma in situ).\n* History of thrombotic diseases (e.g., deep vein thrombosis, pulmonary embolism, stroke), known bleeding diathesis or coagulation dysfunction, major thrombotic event within 6 months, or any coagulation parameter ≥1.5x ULN, or clinically significant abnormal coagulation function deemed unsuitable by the investigator.\n* Long-term use (over 1 month) or current use of anticoagulants (e.g., warfarin, rivaroxaban, dabigatran) or antiplatelet drugs (e.g., aspirin, clopidogrel) before screening.\n* Diagnosis of significant cardiovascular or cerebrovascular disease within 6 months before screening, including but not limited to acute stroke, transient ischemic attack (TIA), acute coronary syndrome, coronary heart disease, heart failure, arrhythmia requiring treatment, etc.\n* History of gout or gout attack within 6 months before screening or before enrollment.\n* Untreated or poorly controlled hypertension (systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg) at screening or before enrollment. Patients on antihypertensive therapy must have a stable regimen and dose for 1 month. If BP criteria are not met at screening\u002Fenrollment, one re-test is allowed. Exclusion if both readings fail.\n* Heart rate at rest (after at least 10 min) \\\u003C50 bpm or \\>100 bpm at screening or before enrollment. One re-test is allowed. Exclusion if both readings fail.\n* PR interval \\>210 ms and\u002For QRS complex duration \\>120 ms, and\u002For QTcF \\>450 ms at rest at screening or before enrollment. If criteria not met, repeat ECG twice on the same day; use the average of 3 measurements for judgment.\n* History of clinically significant chronic or acute exacerbating respiratory diseases, including but not limited to asthma, COPD (excluding obstructive sleep apnea).\n* History of severe gastrointestinal disease (e.g., active ulcer, gastroparesis, pyloric obstruction, inflammatory bowel disease) within 6 months before screening or before enrollment, or gastrointestinal surgery, or long-term use of drugs directly affecting GI motility due to chronic GI disease, deemed unsuitable by the investigator.\n* Severe renal disease or estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m² (CKD-EPI formula) at screening or before enrollment.\n* Serum amylase or lipase \\>3x Upper Limit of Normal (ULN) at screening or before enrollment, or history\u002Fknown chronic pancreatitis, acute pancreatitis, pancreatic injury.\n* History of cholelithiasis, acute or chronic cholecystitis (except those with no residual biliary stones post-treatment or post-cholecystectomy without sequelae, deemed eligible by the investigator).\n* Severe dyslipidemia, with LDL-C ≥4.40 mmol\u002FL or triglycerides (TG) ≥5.65 mmol\u002FL at screening or before enrollment. If on lipid-lowering therapy, regimen and dose must be stable for 1 month.\n* Clear history of psychiatric disorders (e.g., depression, schizophrenia, bipolar disorder) within 2 years before screening.\n* Major surgery within 1 month before screening, or presence of severe infection or active inflammation.\n* History of blood donation \\>400 mL, transfusion, or blood loss within 90 days before screening or before enrollment.\n* Any of the following laboratory abnormalities at screening or before enrollment: 1. ALT or AST \\>2x ULN; 2. Total Bilirubin \\>1.5x ULN; 3. Calcitonin ≥35 pg\u002FmL; 4. Hemoglobin \\\u003C110 g\u002FL (female) or \\\u003C120 g\u002FL (male); 5. Clinically significant abnormal platelet count; 6. Clinically significant abnormal white blood cell or neutrophil count;\n* Use of any approved or unapproved weight-affecting drugs or products within 3 months before screening, including but not limited to orlistat, phentermine-topiramate, naltrexone-bupropion, systemic corticosteroids, antidepressants (SSRIs, SNRIs, tricyclics, tetracyclics), antipsychotics\u002Fsedatives (e.g., imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid, lithium), etc.\n* Use of any DPP-4 inhibitor, or GLP-1, GIP, GCG receptor agonists, or FGF-21 within 6 months before screening.\n* History of bariatric surgery (except liposuction\u002Fabdominoplasty \\>1 year prior).\n* Participation in any drug or medical device clinical trial within 3 months before screening or before enrollment (except screen failures).\n* Positive serology for HBsAg, anti-HCV antibody, anti-TP antibody, or anti-HIV antibody at screening.\n* History of drug abuse and\u002For alcoholism (weekly alcohol intake \\>14 units) within 6 months before screening\n* Positive urine drug screen or alcohol breath test at screening.\n* Pregnant or lactating females, or subjects using oral contraceptives.\n* Intolerance to venipuncture or history of needle syncope, blood-injury syncope.\n* Any other physiological, psychological, or situational condition deemed by the investigator as unsuitable for trial participation.","65 Years",{"count":139,"type":21},9,[141],"EARLY_PHASE1","Primary Objectives:\n\n•To evaluate the safety and tolerability of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059）in Chinese subjects with T2DM.\n\nSecondary Objectives:\n\n* To characterize the pharmacokinetic (PK) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（CR059） in Chinese subjects with T2DM;\n* To characterize the pharmacodynamic (PD) profile of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n* To evaluate the immunogenicity of a single dose of Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059） in Chinese subjects with T2DM;\n\nParticipants :\n\nDiagnosed with T2DM for at least 3 months but less than 5 years, according to the Chinese Diabetes Society's diagnostic criteria",[28],"2026-03-31",{"date":146,"type":34},"2026-04-06",{"date":148,"type":34},"2026-01-20",{"date":150,"type":21},"2026-08-31",{"name":152,"class":69},"The First Affiliated Hospital of Henan University of Science and Technology",{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":105},"100631092","phase-2-a-mechanistic-study-on-the-effect-of-htd1801-versus-placebo-on-kidney-function-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-100631092","NCT07496177","A Mechanistic Study on the Effect of HTD1801 Versus Placebo on Kidney Function in Patients With Type 2 Diabetes and Chronic Kidney Disease.","A Randomized, Double-blind, Placebo-controlled Mechanistic Study to Evaluate the Effect of HTD1801 in Delaying the Progression of Renal Impairment in Patients With Type 2 Diabetes and Chronic Kidney Disease.","Negentropy","Inclusion Criteria:\n\n\\-\n\nSubjects must meet all of the following criteria to be eligible for the study:\n\n1. Male or female, aged between 18 and 75 years (inclusive) at the time of signing the informed consent form.\n2. Clinically diagnosed with Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD) before screening, evidenced by:\n\n   1. A urine albumin-to-creatinine ratio (UACR) \\>200 mg\u002Fg on at least two separate occasions before screening.\n   2. A clinical diagnosis of CKD (KDIGO stage G1 to G3b) for at least 3 months, and an estimated glomerular filtration rate (eGFR) between 30 and 120 ml\u002Fmin\u002F1.73 m² at screening (using the CKD-EPI creatinine-cystatin C formula).\n3. Confirmed diagnosis of T2DM. If on medication for T2DM, the dose must have been stable for at least 3 months before enrollment. At screening, HbA1c must be ≤9%.\n4. At screening, on a stable, maximum tolerated or recommended dose of a RAAS inhibitor (e.g., valsartan, irbesartan) for at least 4 weeks. If not on a RAAS inhibitor, must be on at least one other stable, guideline-recommended kidney-protective drug (e.g., GLP-1RA, SGLT-2i, or non-steroidal MRA like finerenone) for at least 4 weeks.\n5. Body Mass Index (BMI) at screening between 18.5 kg\u002Fm² and 40 kg\u002Fm². Weight must be stable (no loss \\>10% in the 3 months before baseline) with no major lifestyle changes in the 3 months before screening.\n6. For women of childbearing potential and sexually active men with partners of childbearing potential: agreement to use highly effective contraception or practice abstinence throughout the study and for 30 days after the last dose.\n7. Able to understand, sign the informed consent form, and comply with the study protocol.\n\nExclusion Criteria:\n\n* Exclusion Criteria Subjects who meet any of the following criteria are excluded from participation in the study. Exclusion criteria based on lab values refer to the most recent results obtained prior to randomization.\n\nKidney Disease:\n\n1. Congenital or hereditary kidney diseases, including polycystic kidney disease, autoimmune kidney diseases (e.g., glomerulonephritis), or congenital urinary tract malformations.\n2. Currently receiving (or within the past 90 days) chronic or intermittent hemodialysis or peritoneal dialysis.\n\n   Liver Disease:\n3. Clinically or histologically confirmed liver cirrhosis (Fibrosis Stage 4).\n4. History of hepatic decompensation (e.g., ascites, hepatic encephalopathy, or variceal bleeding).\n5. Presence of the following acute or chronic liver diseases at screening: autoimmune hepatitis, primary biliary cholangitis, alcoholic liver disease, Wilson's disease, or drug-induced liver injury.\n\n   Gastrointestinal Disease:\n6. History of gastric bypass surgery.\n7. History of peptic or gastrointestinal ulcer within 12 months prior to randomization.\n8. History of clinically active inflammatory bowel disease within 12 months prior to randomization.\n9. Severe gastrointestinal disease at screening that affects drug absorption, distribution, metabolism, or excretion, including chronic conditions causing recurrent diarrhea (e.g., irritable bowel syndrome, ulcerative colitis, Crohn's disease).\n\n   Cardiovascular Disease:\n10. History of myocardial infarction, stroke, uncontrolled arrhythmia, unstable angina, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening.\n11. Current or previous history of New York Heart Association (NYHA) Class IV congestive heart failure.\n12. Planned coronary, carotid, or peripheral arterial revascularization.\n13. Uncontrolled hypertension despite antihypertensive therapy, defined as sustained SBP \\>150 mmHg and\u002For DBP \\>100 mmHg.\n\n    Hematologic Disease:\n14. Hematologic disorders or any condition causing hemolysis or red blood cell instability at screening, including but not limited to: glucose-6-phosphate dehydrogenase (G-6-PD) deficiency, hemolytic anemia, iron deficiency anemia, aplastic anemia, chronic malaria, splenectomy, reticulocytopenia.\n\n    Oncology:\n15. History of or current malignancy within the past 2 years, except for basal cell carcinoma or excised non-invasive squamous cell carcinoma of the skin.\n16. Current, planned, or anticipated treatment with radiotherapy, cytotoxic chemotherapy, or immunomodulators (e.g., interleukins, interferons). Long-term stable use of immunosuppressants is permitted if approved by the investigator.\n\n    Diagnostic Assessments:\n17. Clinically significant laboratory abnormalities or ECG changes at screening, including but not limited to:\n\n    1. Platelet count \\\u003C150,000\u002Fmm³.\n    2. International Normalized Ratio (INR) \\>1.3.\n    3. Alkaline Phosphatase (ALP) \\>2 × Upper Limit of Normal (ULN).\n    4. Total bilirubin \\>1.3 × ULN, unless the subject has Gilbert's syndrome.\n    5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥5 × ULN.\n    6. Corrected QT interval (QTc) \\>450 ms for males or \\>470 ms for females (Fridericia's formula).\n18. Active severe infection requiring parenteral antibiotic or antifungal therapy within 30 days prior to or at screening.\n19. Evidence of the following viral infections at screening:\n\n    1. Human Immunodeficiency Virus (HIV) infection: defined as positive HIV antibody.\n    2. Syphilis infection: defined as positive Treponema pallidum antibody (TP-Ab).\n    3. Active Hepatitis B Virus (HBV) infection: defined as positive Hepatitis B surface antigen (HBsAg) OR positive Hepatitis B core antibody (HBcAb) with HBV-DNA \\>500 IU\u002FmL or \\>2000 copies\u002FmL.\n    4. Active Hepatitis C Virus (HCV) infection: defined as positive HCV antibody (HCV-Ab) with HCV-RNA above the ULN.\n\n    Other:\n20. Major surgery within 30 days prior to screening.\n21. History of solid organ transplantation or being on a waiting list for such transplantation.\n22. Blood donation or blood loss ≥400 mL within 3 months prior to screening, or anticipated need for blood transfusion within 12 weeks after randomization.\n23. Known exposure to UDCA（Ursodeoxycholic Acid） or BBR（Berberine） within 3 months prior to screening, or known allergy to UDCA or BBR.\n24. History or evidence of Type 1 diabetes.\n25. Female subjects who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential and not using highly effective contraception.\n26. Participation in any clinical study of an approved or investigational product within 30 days prior to screening.\n27. Any condition that, in the investigator's judgment, may jeopardize the subject's safety or compliance with the study protocol.",{"count":162,"type":21},75,[24],"Goal: The goal of this clinical trial is to learn if the investigational drug HTD1801 can slow the progression of kidney damage in adults diagnosed with both Type 2 Diabetes (T2DM) and Chronic Kidney Disease (CKD).\n\nMain Question it Aims to Answer:\n\n▪ Does HTD1801 result in a greater reduction (or a smaller increase) in urine albumin-to-creatinine ratio (UACR) compared to a placebo?\n\nResearchers will compare the group receiving HTD1801 to the group receiving a placebo to see if HTD1801 is more effective in slowing kidney function decline.\n\nParticipants will:\n\n* Undergo screening tests to determine eligibility.\n* Be randomly assigned to receive either HTD1801 capsules or matching placebo capsules twice daily for 12 weeks.\n* Take the study medication twice daily for 12 weeks.\n* Attend scheduled clinic visits (weekly for the first 4 weeks, then every 4 weeks) for assessments and check-ups.\n* Have their safety monitored through reporting of any health changes and routine lab tests.",[28,166],"CKD","2026-03-22",{"date":169,"type":34},"2026-03-27",{"date":171,"type":21},"2026-05-01",{"date":173,"type":21},"2027-06-30",{"name":175,"class":69},"Institute of Medicinal Biotechnology, Chinese Academy of Medical Sciences",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":4,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":183,"targetDuration":4,"studyType":22,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":195,"leadSponsor":197,"locationsCount":4},"100615218","phase-4-the-effect-of-alogliptin-combined-with-actoplus-met-on-glucose-and-lipid-metabolism-and-pancreatic-function-in-patients-with-t2dm-complicated-with-mafld-100615218","NCT07289750","The Effect of Alogliptin Combined With Actoplus Met on Glucose and Lipid Metabolism and Pancreatic Function in Patients With T2DM Complicated With MAFLD","The Effect of Alogliptin Combined With Pioglitazone and Metformin Hydrochloride Tablets on Glucose and Lipid Metabolism and Islet Function in Patients With Type 2 Diabetes Mellitus Complicated With Metabolic Dysfunction-associated Fatty Liver Disease","Inclusion Criteria:\n\n* Clinical diagnosis of T2DM\n* Clinical diagnosis of MAFLD\n* HbA1c: 6.5-9.5%\n* BMI: 19-35 kg\u002Fm2\n* No hypoglycemic drugs or insulin have been used within half a year\n\nExclusion Criteria:\n\n* Severe infections, surgeries and other emergency\n* Other types of diabetes\n* Severe cardiovascular, brain, liver and kidney disorders\n* Malignant tumor",{"count":184,"type":21},80,[186],"PHASE4","To compare the efficacy and safety of the combination of alogliptin and actoplus met with that of actoplus met alone in improving the glucose and lipid metabolism and pancreatic function in T2DM patients complicated with MAFLD.",[28,189],"MAFLD",[28,189],"2026-03-20",{"date":193,"type":34},"2026-03-24",{"date":171,"type":21},{"date":196,"type":21},"2027-08-31",{"name":198,"class":69},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":206,"minAge":17,"maxAge":113,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":105},"100588499","effects-of-calcium-on-gut-functions-and-blood-glucose-in-humans-with-type-2-diabetes-100588499","NCT06942195","Effects of Calcium on Gut Functions and Blood Glucose in Humans With Type 2 Diabetes","Effects of Intraduodenal Calcium on Plasma Glucose, Glucoregulatory Hormones and Gastric Emptying in Response to a Mixed-nutrient Drink in Humans With Type 2 Diabetes","Inclusion Criteria:\n\n* Males with type 2 diabetes mellitus (T2DM). Diagnosis of T2DM will be based on WHO criteria. Only males will be included to avoid the confounding effects of the menstrual cycle on gastric emptying.\n* BMI: 28-38 kg\u002Fm².\n* HbA1c \\>=6.5 - \\\u003C=7.9% at screening.\n* Blood glucose medications will be required to be withheld for 48 hours prior to each study day.\n* Weight-stable (i.e. \\\u003C5% fluctuation) at study entry, which will be ascertained by a stable body weight in the preceding 3 months.\n\nExclusion Criteria:\n\n* Significant GI symptoms, or history of GI disease or surgery\n* Current gallbladder or pancreatic disease\n* Cardiovascular or respiratory diseases\n* Any other illnesses (except type 2 diabetes) as assessed by the investigator - (including chronic illnesses not explicitly listed above)\n* Use of prescribed or non-prescribed medications (including vitamins and herbal supplements) which may affect energy metabolism, GI function, bodyweight or appetite (e.g. domperidone, cisapride, anticholinergic drugs (e.g. atropine), metoclopramide, erythromycin, hyoscine, orlistat, green tea extracts, Astragalus, St Johns Wort etc.)\n* Lactose intolerance\u002Fother food allergy(ies)\n* Individuals with low ferritin levels (\\\u003C30 ng\u002FmL), or who have donated blood in the 12 weeks prior to taking part in the study\n* High performance athletes\n* Current intake of \\> 2 standard drinks on \\> 5 days per week (\\>140g\u002Fweek)\n* Current smokers of tobacco (cigarettes, cigars, pipes, sheesha, chewing, vaping etc.)\n* Current use of recreational drugs, e.g. marijuana\n* Current intake of any illicit substance\n* Vegetarians\n* Inability to tolerate nasoduodenal tube\n* Inability to comprehend study protocol\n* HbA1c \\\u003C6% or \\>7.9%\n* Estimated glomerular filtration rate \\\u003C45 ml\u002Fmin\n* Any patient whose medication cannot be withheld for 48 hours for medical reasons","MALE",{"count":208,"type":21},8,[210],"NA","The intervention in this study consists of a 75-min intraduodenal infusion of an isotonic solution containing either of calcium chloride (CaCl2) or control (saline).\n\nParticipants enrolled into the study will receive, in randomised, double-blind fashion (i) Saline (control), (ii) 500 mg CaCl2, or (iii) 1000 mg CaCl2 in three separate sessions, each of which will be separated by at least 4 (and up to 10) days. Each study session will be 4-6 hours. Studies will be carried out in the Clinical Research Facility of the Adelaide Medical School, the University of Adelaide, by staff and students trained in the required techniques.",[28],[214,215,216,217,218,219],"Intraduodenal","Calcium","Gastric emptying","Glucoregulatory hormones","Plasma glucose","Human","2025-12-18",{"date":222,"type":34},"2025-12-26",{"date":224,"type":34},"2025-05-22",{"date":226,"type":21},"2026-04-28",{"name":228,"class":69},"University of Adelaide",{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":235,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":237,"targetDuration":4,"studyType":22,"phases":239,"briefSummary":240,"conditions":241,"keywords":246,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":105},"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":238,"type":21},60,[210],"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.",[242,83,28,85,243,244,245],"Nutrition","Diabetes Education","Diabetes Type 2","Diabetes Mellitis",[247,28,242,248,249,83,250,251],"Diabetes","Food is Medicine","Continuous glucose monitor","Food insecurity","Nutrition insecurity","2025-11-10",{"date":254,"type":34},"2025-11-12",{"date":256,"type":34},"2025-09-19",{"date":258,"type":21},"2026-06",{"name":260,"class":69},"University of North Carolina, Chapel Hill",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":11,"sex":16,"minAge":268,"maxAge":18,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":276,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":105},"100605641","phase-4-the-effect-of-semaglutide-on-bone-health-100605641","NCT07165158","The Effect of Semaglutide on Bone Health","The Effect of Semaglutide on Osteoporotic Fractures in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n1. Type 2 diabetes (according to WHO diagnostic criteria),\n2. Age range: 50 to ≦75 years,\n3. Glycosylated hemoglobin (HbA1c): 6.5 to ≦9.0%,\n4. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \\\u003C -1, or history of fragility fractures (hip, vertebral, distal forearm, or proximal humerus fractures) within three years before screening,\n5. No use of antidiabetic medications in 8 weeks prior to enrollment (excluding metformin).\n\nExclusion Criteria:\n\n1. Bone mineral density (lumbar spine, hip, or femoral neck) T-score \\\u003C -2.5,\n2. History of secondary osteoporosis,\n3. Serious liver dysfunction or chronic kidney disease (aspartate aminotransferase (AST) or alanine transaminase (ALT) \\> 2.5 times the upper limit of the normal reference, or estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73㎡),\n4. History of malignant tumors,\n5. Received strong anti-osteoporosis medications such as bisphosphonates, denosumab, or teriparatide within the past 2 years,\n6. History of pancreatitis or triglyceride levels \\>5.6 mmol\u002FL;\n7. Family history of medullary carcinoma.","50 Years",{"count":270,"type":21},150,[186],"Semaglutide has effects that include lowering blood sugar, reducing weight, and improving cardiovascular and renal outcomes, and it is now widely used in clinical practice. Given that weight loss is associated with bone loss, its effect on bone health has recently raised concerns. Therefore, the goal of this clinical trial is to learn the effect of semaglutide on bone mineral density and fractures in patients with type 2 diabetes.\n\nThe investigators will compare semaglutide combined with metformin to metformin alone to see if semaglutide treatment has effects on bone mineral density and bone turnover markers in patients with type 2 diabetes after 12 months.\n\nThe intervention group will receive semaglutide combined with metformin for 12 months, while the control group will receive metformin alone for the same duration. After 12 months of treatment, the investigators will compare the bone mineral density, fracture incidence, and levels of bone turnover markers between the two groups.",[274,275,28],"Osteoporosis","Osteoporosis Fracture",[277,278,28],"antidiabetic drug","osteoporosis fracture","2025-09-11",{"date":281,"type":34},"2025-09-17",{"date":283,"type":21},"2025-09-15",{"date":285,"type":21},"2026-12-31",{"name":287,"class":69},"The First Affiliated Hospital of Xiamen University",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":105},"100603671","phase-3-a-study-of-ray1225-versus-semaglutide-as-add-on-therapy-to-oral-antidiabetic-drugs-in-participants-with-type-2-diabetes-100603671","NCT07139548","A Study of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Participants With Type 2 Diabetes","A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of RAY1225 Versus Semaglutide as Add-on Therapy to Oral Antidiabetic Drugs in Patients With Type 2 Diabetes","Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Have HbA1c between ≥7.0% and ≤11.5%\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg\u002Fm²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\\u003C3.0 mmol\u002FL) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation\u002Floss ≥400 mL within 12 weeks prior to screening, or blood donation\u002Floss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).",{"count":296,"type":21},600,[298],"PHASE3","The reason for this study is to compare the effect of the study drug RAY1225 to semaglutide on blood sugar levels in participants with type 2 diabetes.",[28],"2025-08-17",{"date":303,"type":34},"2025-08-24",{"date":305,"type":21},"2025-08-31",{"date":285,"type":21},{"name":308,"class":41},"Guangdong Raynovent Biotech Co., Ltd",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":22,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":323,"leadSponsor":324,"locationsCount":105},"100603670","phase-3-a-study-of-ray1225-in-participants-with-type-2-diabetes-not-controlled-with-diet-and-exercise-alone-100603670","NCT07139535","A Study of RAY1225 in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone","A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of RAY1225 Versus Placebo in Patients With Type 2 Diabetes, Inadequately Controlled With Diet and Exercise Alone","Inclusion Criteria:\n\n1. Have been diagnosed with type 2 diabetes mellitus (T2DM)\n2. Having received only dietary and exercise therapy and never taken any antihyperglycemic medications before screening; OR Having taken no antihyperglycemic medications within the 12 weeks before screening and, prior to that, having received only oral antihyperglycemic drugs in a regimen of no more than two concomitant agents.\n3. Have a body mass index (BMI) ≥20 kilograms per meter squared (kg\u002Fm²) at screening\n4. Be of stable weight (±5%) for at least 12 weeks before screening\n\nExclusion Criteria:\n\n1. Have type 1 diabetes mellitus\n2. Presence of severe chronic diabetic complications at screening, including but not limited to: proliferative diabetic retinopathy, diabetic macular edema, and severe non-proliferative diabetic retinopathy requiring acute treatment;\n3. History of diabetic ketoacidosis or hyperosmolar hyperglycemic state within 24 weeks prior to randomization;\n4. Occurrence of a Grade 3 hypoglycemic event within 12 months prior to screening, or ≥3 Grade 2 hypoglycemic events (venous or capillary blood glucose \\\u003C3.0 mmol\u002FL) within 3 months prior to screening, or presence of hypoglycemia-related symptoms ;\n5. History of severe trauma, severe infection, or surgery within 12 weeks prior to screening that may affect glycemic control;\n6. Receipt of blood transfusion within 12 weeks prior to screening, or blood donation\u002Floss ≥400 mL within 12 weeks prior to screening, or blood donation\u002Floss ≥200 mL within 4 weeks prior to screening, or known hemoglobinopathy (such as thalassemia, hemolytic anemia, sickle cell anemia, etc.);\n7. Any unstable or treatment-requiring endocrine disorders related to glycemic control other than type 2 diabetes mellitus (such as hyperthyroidism, acromegaly, Cushing's syndrome, etc.).",{"count":317,"type":21},350,[298],"The goal for this study is to evaluate the efficacy and safety of RAY1225 versus placebo in participants with type 2 diabetes not under control with diet and exercise alone.",[28],{"date":303,"type":34},{"date":305,"type":21},{"date":285,"type":21},{"name":308,"class":41},{"id":326,"slug":327,"hasResults":11,"nctId":328,"briefTitle":329,"officialTitle":330,"acronym":4,"eligibilityCriteria":331,"healthyVolunteers":11,"sex":16,"minAge":332,"maxAge":4,"enrollmentInfo":333,"targetDuration":4,"studyType":22,"phases":335,"briefSummary":336,"conditions":337,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":340,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":105},"100600129","phase-3-efficacy-and-safety-of-add-on-therapy-with-empagliflozin-in-patients-with-type-2-diabetes-on-a-background-of-alogliptin-and-metformin-100600129","NCT07093476","Efficacy and Safety of Add-On Therapy With Empagliflozin in Patients With Type 2 Diabetes on a Background of Alogliptin and Metformin","A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Clinical Trial and Open-Label Extension Study to Evaluate the Efficacy and Safety of Add-On Therapy With Empagliflozin for Patients With Inadequately Controlled Type 2 DiabetesMellitus in the Combination Treatment With Metformin and Alogliptin","Inclusion Criteria:\n\n* Adults at the time of signing the Informed Consent Form (ICF)\n* Signed the written ICF voluntarily after being fully informed of the objectives, methods, and effects of the study\n* Diagnosed with T2DM\n\nExclusion Criteria:\n\n* Diagnosed with other types of diabetes than T2DM\n* History of hypersensitivity reaction to the components or drugs of the same class as the IP or the background therapy\n* Uncontrolled severe complications of diabetes","19 Years",{"count":334,"type":21},171,[298],"Phase 3 study to assess the Efficacy and Safety of CT-L02-301 in Type 2 Diabetes Patients with Insufficient Glycemic Control with Metformin and Alogliptin Combination Therapy.",[28,338,339],"Diabete Type 2","DM","2025-08-07",{"date":342,"type":34},"2025-08-11",{"date":344,"type":34},"2025-07-18",{"date":346,"type":21},"2027-04",{"name":348,"class":41},"Celltrion",{"id":350,"slug":351,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":356,"targetDuration":4,"studyType":22,"phases":358,"briefSummary":359,"conditions":360,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":128},"100594405","phase-4-cofrogliptin-once-every-2-weeks-as-add-on-therapy-to-metformin-and-dapagliflozin-versus-daily-linagliptin-in-patients-with-type-2-diabetes-100594405","NCT07019012","Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes.","Cofrogliptin Once Every 2 Weeks as Add-on Therapy to Metformin and Dapagliflozin Versus Daily Linagliptin in Patients With Type 2 Diabetes: A Multicenter, Randomized, Open-Label, Active-Controlled, Non-inferiority Trial","Inclusion Criteria:\n\n* Able to understand and voluntarily sign a written informed consent form.\n* Male or female subjects aged 18 years and above .\n* Meet the diagnostic criteria for Type 2 Diabetes Mellitus (T2DM).\n* Have been on initial SGLT2i monotherapy (dapagliflozin) at a dose of 10 mg daily for at least 12 weeks.\n* Have received metformin treatment for ≥12 weeks, with a stable dose maintained during the screening period (≥1500 mg\u002Fday if tolerable or at the maximum tolerated dose (\\\u003C1500 mg\u002Fday but ≥1000 mg\u002Fday), and no dosage adjustment).\n* HbA1c levels within the range: 7.0% \\\u003C HbA1c ≤ 10.0%.\n* Fasting plasma glucose (FPG) \\\u003C 15 mmol\u002FL.\n* Body Mass Index (BMI) ≤ 40 kg\u002Fm2.\n* Estimated Glomerular Filtration Rate (eGFR) ≥ 60 ml\u002Fmin\u002F1.73m2.\n* Agree to maintain the same diet and exercise habits throughout the trial period, willing and able to accurately use a home blood glucose meter for self-monitoring of blood glucose (SMBG) and keep records.\n\nExclusion Criteria:\n\n* Type 1 Diabetes Mellitus.\n* Any type of secondary diabetes.\n* Pending or having undergone pancreatic or β-cell transplantation.\n* History of pancreatitis or pancreatic resection.\n* Complicated with diabetic ketoacidosis or hyperosmolar coma.\n* Moderate or severe hepatic insufficiency of any cause. Hepatic insufficiency is defined as screening period levels of ALT (SGPT), AST (SGOT), or alkaline phosphatase serum levels exceeding 3 times the upper limit of normal (ULN).\n* Acute coronary syndrome (ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, unstable angina), stroke, or transient ischemic attack (TIA) within the last 3 months.\n* Uncontrolled hypertension: systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.\n* Hemoglobin levels \\\u003C 10 g\u002Fl or 100 mg\u002Fdl.\n* More than 2 recurrent genitourinary infections within the last 3 months.\n* History of bariatric surgery or other gastrointestinal surgeries leading to chronic malabsorption within the last 2 years.\n* Weight instability due to anti-obesity medication within the last 3 months or any other treatment (such as surgery, aggressive diet plans) at screening.\n* History of cancer (excluding basal cell carcinoma) and\u002For cancer treatment within the last 5 years.\n* Human Immunodeficiency Virus (HIV) infection.\n* Severe peripheral vascular disease.\n* Hematological malignancy or any disorder causing hemolysis or erythrocyte instability (e.g., malaria, babesiosis, hemolytic anemia).\n* Concurrent immune system diseases or currently receiving systemic corticosteroid therapy.\n* Changes in thyroid hormone dosage within the last 6 weeks, or any other uncontrolled endocrine or metabolic disorder outside of T2DM.\n* Alcohol or drug abuse within the last 3 months that may reduce trial compliance, or any chronic condition deemed by the investigator as likely to reduce study compliance or medication adherence.\n* Known allergy to the trial medication components or other chemically similar drugs or excipients.\n* Pregnant women, women planning pregnancy during the study or breastfeeding, subjects unwilling to use reliable contraception (including condoms, spermicides, or intrauterine devices) from signing the informed consent form until 28 days after the last dose of trial medication, or women planning to use progesterone-containing contraceptives during this period. Men with plans for conception during the study.\n* Participation in any other clinical study within the last 30 days.",{"count":357,"type":21},170,[186],"This study is designed to evaluate the change in glycated hemoglobin (HbA1c) levels from baseline to 24 weeks after the combination therapy of cofrogliptin, metformin and SGLT2i (dapagliflozin) in type 2 diabetes mellitus (T2DM) patients with poor control of glucose level by metformin and SGLT2i combination therapy.",[28],"2025-06-05",{"date":363,"type":34},"2025-06-13",{"date":365,"type":21},"2025-07-30",{"date":367,"type":21},"2026-12-30",{"name":369,"class":69},"Huazhong University of Science and Technology",{"id":371,"slug":372,"hasResults":11,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":377,"targetDuration":4,"studyType":22,"phases":379,"briefSummary":380,"conditions":381,"keywords":383,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":397},"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":378,"type":21},115,[210],"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.",[382,85,28],"Type 2 Diabetic Patients",[28,384,385,386],"beinaglutide","CSII","subcutaneous pump","2025-04-30",{"date":389,"type":34},"2025-05-02",{"date":391,"type":34},"2019-07-02",{"date":393,"type":21},"2025-12",{"name":395,"class":396},"Beijing Hospital","OTHER_GOV",16,{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":402,"acronym":4,"eligibilityCriteria":403,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":404,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":406,"conditions":407,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":105},"100580899","the-intelligent-prevention-and-control-system-and-strategy-for-the-whole-disease-cycle-of-diabetic-nephropathy-100580899","NCT06843304","The Intelligent Prevention And Control System And Strategy For The Whole Disease Cycle Of Diabetic Nephropathy","T2DM\n\nInclusion Criteria:\n\n* Age ≥18 years old, gender is not limited\n* Diagnosed with type 2 diabetes\n* A history of type 2 diabetes for more than 5 years\n* Negative proteinuria\n* Creatinine is normal\n* Good compliance, voluntarily sign informed consent\n\nExclusion Criteria:\n\n* Incomplete medical records\n* Lack of fundus microvascular examination or new imaging technology examination results data\n* Combined with autoimmune diseases and tumors\n\nType 2 diabetes patients undergoing renal biopsy\n\nInclusion Criteria:\n\n* Age ≥18 years old, gender is not limited\n* Diagnosed with type 2 diabetes\n* Kidney damage (microalbuminuria or dominant albuminuria or renal insufficiency)\n* Have undergone renal puncture biopsy and have complete renal pathological diagnosis data\n* Sign informed consent voluntarily\n\nExclusion Criteria:\n\n* Gestational diabetes mellitus, special type diabetes mellitus\n* Patients with hereditary kidney disease\n* Combined with autoimmune diseases\n* Diabetic nephropathy The indicators in the comprehensive assessment model of the risk of renal progression could not be obtained\n* There were pregnancy plans in the study period",{"count":405,"type":21},2000,"Diabetic nephropathy is one of the most severe microvascular complications of diabetes and a major cause of premature death and disability. It has become a leading cause of end-stage renal failure both in China and worldwide, consuming substantial medical resources. The establishment of a comprehensive regulatory system for the development and progression of diabetic nephropathy is a critical need for effective prevention and control. However, there is a lack of representative cohorts covering the entire disease cycle of diabetic nephropathy both domestically and internationally, creating technical bottlenecks in comprehensively describing its developmental patterns. This project aims to expand and integrate existing large-sample natural population cohorts and prospective follow-up cohorts covering the entire disease cycle of diabetes and diabetic nephropathy. It will construct a panoramic life database to identify risk factors, clinical phenotypes, and multimodal biomarkers at different disease stages. By integrating multi-organ interactions (e.g., kidney, eye), the project will establish novel imaging and functional assessment technologies for microvascular complications. Utilizing artificial intelligence to process multimodal medical data, it will build and validate risk prediction models and evaluation systems for the entire disease cycle of diabetic nephropathy. The project will develop effective intelligent prevention and treatment strategies for diabetic nephropathy, promote the adoption of new technologies, and establish a medical quality control system to provide services for medical institutions. Ultimately, it aims to improve and sustain medical quality, reducing the incidence of end-stage renal disease.",[408,28],"Diabetic Nephropathy","2025-04-16",{"date":411,"type":34},"2025-04-20",{"date":413,"type":34},"2024-01-01",{"date":415,"type":21},"2027-12",{"name":417,"class":69},"Chinese PLA General Hospital",{"id":419,"slug":420,"hasResults":11,"nctId":421,"briefTitle":422,"officialTitle":422,"acronym":4,"eligibilityCriteria":423,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":424,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":426,"conditions":427,"keywords":428,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":105},"100568815","comprehensive-clinical-evaluation-study-of-glp-1ra-100568815","NCT06686134","Comprehensive Clinical Evaluation Study of GLP-1RA","Inclusion Criteria:\n\n* Diagnosed with type 2 diabetes;\n* no study drug has been used in the last three months;\n* Existing hypoglycemic programs include investigational drugs;\n* Age ≥18 years old;\n* The patient's demographic data, disease history, course records, laboratory test indicators, drug use and other information were complete;\n* Sign informed consent.\n\nExclusion Criteria:\n\n* persistent influenza, autoimmune disease, or other metabolic disease;\n* There are obvious gastrointestinal diseases, gastrointestinal resection or malabsorption syndrome;\n* diet drugs, glucocorticoids, drugs affecting gastrointestinal motility are being used;\n* Patients with severe liver and kidney function impairment and patients with malignant tumors;\n* Pregnant or lactating women.",{"count":425,"type":21},492,"The objective of this project is to identify the most efficacious glucagon-like peptide-1 receptor agonists (GLP-1RAs) for the treatment of adult patients with type 2 diabetes mellitus (T2DM). In accordance with the index system and evaluation rules set forth in the Management Guidelines for Comprehensive Clinical Evaluation of Drugs, the effects of GLP-1RAs drugs in real-world settings are tracked, summarised, and analysed across six dimensions: safety, effectiveness, economy, innovation, appropriateness, and accessibility. This is done with the objective of ensuring that these drugs are fully utilised in accordance with their potential benefits. The objective is to ascertain the role of medical institutions as the principal entity responsible for the comprehensive evaluation of the clinical application of drugs and to provide data that will reduce the risk of using GLP-1RAs drugs. Moreover, the objective is to ascertain the advantages of their clinical application and to guarantee the safe and rational use of drugs for patients with type 2 diabetes mellitus. The objective of this study is to facilitate the fulfilment of medical institutions' role as the primary entity responsible for the comprehensive evaluation of the clinical application of medicines. Furthermore, the study will provide data that can be used to reduce the risk of using GLP-1RAs drugs, explore the advantages of their clinical application, and guarantee the safe and rational use of medicines for patients with type 2 diabetes.",[28],[429],"GLP1-RA","2024-11-12",{"date":432,"type":34},"2024-11-13",{"date":434,"type":34},"2024-07-01",{"date":436,"type":21},"2026-07-31",{"name":438,"class":69},"LI YAN"]