[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type2-diabetes-mellitus\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type2-diabetes-mellitus":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,56,82,111,132,158,182,205,223,257,281],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100641426","phase-3-a-study-of-aleniglipron-in-adults-with-obesity-or-overweight-and-type-2-diabetes-mellitus-accomplish-2-100641426",false,"NCT07654374","A Study of Aleniglipron in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)","A Long-Term Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Multiple Maintenance Doses of Oral Once Daily Aleniglipron for Chronic Weight Management in Adults With Obesity or Overweight and Type 2 Diabetes Mellitus (ACCOMPLISH-2)","Inclusion Criteria:\n\n* Signed Informed Consent\n* Have a BMI ≥27.0 kg\u002Fm2 at Screening\n* Have a diagnosis of T2DM according to the WHO classification or other locally applicable standards, with HbA1c ≥6.5% (≥53 mmol\u002Fmol) to ≤10% (86 mmol\u002Fmol) at Screening\n\nExclusion Criteria:\n\n* Have type 1 diabetes, history of ketoacidosis or hyperosmolar state\u002Fcoma, or any other types of diabetes except T2DM.\n* Have had 1 or more episode of severe hypoglycemia and\u002For 1 or more episode of hypoglycemia unawareness within 180 days prior to Screening.\n* Are currently receiving or planning to receive treatment for diabetic retinopathy and\u002For macular edema\n* Self-reported change in body weight \\>5 kg (11 pounds) within 3 months before Screening.\n* Have prior or planned surgical or non-surgical treatment for obesity.",true,"ALL","18 Years","79 Years",{"count":21,"type":22},1100,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is randomized, double-blind, placebo-controlled study of the long-term efficacy, safety, and tolerability of multiple doses of aleniglipron in participants living with overweight or obesity and T2DM. Participants will be randomized to aleniglipron or placebo for a total of 76 weeks of treatment.",[28,29,30,31],"Obesity","Overweight","Chronic Weight Management","Type2 Diabetes Mellitus",[33,34,35,36,37,38,39,40,41,42],"obesity","overweight","GSBR-1290","aleniglipron","chronic weight management","obese","type 2diabetes mellitus","small molecule","GLP-1","Structure Therapeutics","NOT_YET_RECRUITING","2026-06-17",{"date":46,"type":47},"2026-06-22","ACTUAL",{"date":49,"type":22},"2026-07",{"date":51,"type":22},"2028-11",{"name":53,"class":54},"Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics","INDUSTRY",74,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":4,"eligibilityCriteria":62,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":23,"phases":66,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100643658","phase-1-a-study-of-ono-3310-in-healthy-adult-male-subjects-and-chronic-kidney-disease-patients-with-type-2-diabetes-mellitus-100643658","NCT07619157","A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","A Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Oral Doses of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\nHealthy adult part\n\n1. Japanese healthy adult male subjects\n2. Age at the time of informed consent: 18 to 45\n3. BMI (at screening): 18.5 kg\u002Fm2 to less than 25.0 kg\u002Fm\\^2\n\nChronic kidney disease patient part\n\n1. Chronic kidney disease patients with type 2 diabetes mellitus\n2. Age at the time of informed consent: 18 to less than 65\n3. UACR measured by 24-hour urine collection: 300 mg\u002Fg to less than 3500 mg\u002Fg\n\nExclusion Criteria:\n\nHealthy adult part\n\n1. Subjects who currently receive treatment for or have a history of any of the following diseases: respiratory system, cardiovascular system, psychiatric system, nervous system, gastrointestinal system, immune system, liver, kidney, hematopoietic function, or endocrine function.\n2. Presence or history of severe allergy to drugs or food\n3. Presence or history of drug or alcohol dependence\n\nChronic kidney disease patient part\n\n1. Current symptoms of severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, pulmonary, psychiatric, cardiac, endocrine, neurologic, or cerebral disease\n2. Patients with type 1 diabetes mellitus\n3. Patients with a history of dialysis treatment","64 Years",{"count":65,"type":22},120,[67],"PHASE1","To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of ONO-3310 in healthy Japanese adult male subjects and chronic kidney disease patients with type 2 diabetes mellitus",[31,70],"Chronic Kidney Disease","RECRUITING","2026-06-04",{"date":74,"type":47},"2026-06-08",{"date":76,"type":47},"2026-06-02",{"date":78,"type":22},"2027-11-30",{"name":80,"class":54},"Ono Pharmaceutical Co., Ltd.",1,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":97,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":81},"100633970","snapdandcgmintype2diabetes-100633970","NCT07533604","SnapDandCGMinType2Diabetes","The Effectiveness of an AI-powered Thai Food Analysis (SnapD) and Continuous Glucose Monitoring on Glycemic Control in Patients With Type 2 Diabetes and Overweight or Obesity: A Randomized Controlled Pilot Study","SnapD in T2DM","Inclusion Criteria:\n\n1. Aged 18 to 65 years, male or female at birth\n2. Diagnosed with type 2 Diabetes Mellitus with overweight or obesity (BMI\\>23 kg\u002Fm²)\n3. Hemoglobin A1c (HbA1c) 6.5-9% measured within 3 months prior to the screening date\n4. Willing to maintain their current antidiabetic medication regimen without dose adjustment for the entire 8-week study duration\n5. Must possess an internet-enabled devices e.g. smartphone, tablet compatible with the SnapD application\n6. Able and willing to adhere intervention, including using snapD and CGM\n\nExclusion Criteria:\n\n1. Currently pregnant, plan pregnancy or breastfeeding during the 8-week study period\n2. Current participation in another interventional clinical trial\n3. Current use of insulin or incretin-based therapies (e.g., GLP-1 Receptor Agonists, GIP\u002FGLP-1 Receptor Agonists)\n4. Presence of severe hearing or visual impairment that, in the investigator's judgment, would preclude the participant from safely and effectively using the SnapD application or the CGM device\n5. known contraindication to CGM usage e.g., a history of severe hypersensitivity to the device's materials or adhesive, planing to go on CT-contrasted imaging etc.","65 Years",{"count":92,"type":22},45,[94],"NA","Study Title: The Effectiveness of an AI-powered Thai food analysis (SnapD) and Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes and Overweight or Obesity: A Randomized Controlled Pilot Study Rationale: Effective dietary management is the cornerstone of treating Type 2 Diabetes (T2DM) and obesity. However, traditional manual food logging is often inaccurate and burdensome. While digital tools and Continuous Glucose Monitoring (CGM) have shown promise internationally, there is a lack of validated AI-powered tools specifically designed for Thai cuisine. This study introduces SnapD, an AI-powered platform (utilizing Gemini 2.5 Flash) designed to recognize Thai food, estimate nutritional values, and integrate with CGM data to provide personalized feedback.\n\nThe primary goal of this pilot study is to evaluate the efficacy of the SnapD application, both as a standalone tool and in combination with CGM, compared to Standard of Care in improving glycemic control (HbA1c) over 8 weeks. Additionally, the study aims to assess the feasibility, participant adherence, and safety of these digital interventions to inform a future, fully powered randomized controlled trial.\n\nStudy Design: This is an 8-week, randomized, open-label, parallel-group, superiority pilot study with a 1:1:1 allocation ratio. A total of 45 participants will be enrolled and assigned to one of three arms:\n\n1. Intervention Arm 1: SnapD application + Real-time CGM + Diabetes Self-Management Education and Support (DSMES)\n2. Intervention Arm 2: SnapD application standalone + DSMES\n3. Control Arm: DSMES alone Inclusion Criteria Highlights: Adults (18-65 years) diagnosed with T2D with BMI \\> 23 kg\u002Fm² (overweight\u002Fobesity) with HbA1c between 6.5% and 9.0% with Must possess a compatible smartphone\u002Ftablet Procedures: Baseline (Visit 1): All participants receive 20-30 minutes of DSMES. Intervention groups receive training on SnapD. Arm 1 receives a 15-day CGM sensor.During Study: Intervention arms log meals via SnapD (at least twice daily). Nutritionists conduct bi-weekly follow-up calls to address technical issues and provide support.\n\nEnd-of-Study (Week 8): Assessment of HbA1c, body weight, waist circumference, lipid profile, and patient-reported outcomes (self-care activities and user satisfaction) Primary Outcome: Mean change in HbA1c from baseline to 8 weeks Secondary Outcomes: Changes in Fasting Plasma Glucose (FPG), body weight, waist circumference, and lipid profiles, Diabetes self-management scores (SDSCA questionnaire), User satisfaction with the SnapD application, Incidence of adverse events (hypoglycemia\u002Fhyperglycemia).\n\nSignificance: This study will provide preliminary evidence on the synergistic benefits of AI-driven nutritional feedback and CGM in a Thai-specific context, supporting the development of scalable, culturally adapted digital health technologies for diabetes management.",[31],[98,99,100,28],"AI-powered Thai food analysis","Continuous Glucose Monitoring","Glycemic Control","2026-04-09",{"date":103,"type":47},"2026-04-16",{"date":105,"type":47},"2026-01-20",{"date":107,"type":22},"2026-09-01",{"name":109,"class":110},"Ramathibodi Hospital","OTHER",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":90,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":81},"100589946","clinical-study-to-assess-the-safety-efficacy-and-in-use-tolerability-of-herbal-based-sugar-support-effervescent-tablets-in-type-2-diabetes-mellitus-patients-100589946","NCT06961019","Clinical Study to Assess the Safety, Efficacy and In-Use Tolerability of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus Patients","A Proof-of-Science, Single-Treatment, Two-Group, Clinical Evaluation of Safety, In-Use Tolerability, Efficacy of Herbal-Based Sugar Support Effervescent Tablets in Type-2 Diabetes Mellitus (T2DM) Patients","Inclusion Criteria:\n\n* 1\\) Male and female individuals with the age between 18 to 65 years at the time of consent.\n\n  2\\) Subject diagnosed with T2DM. 3) Subjects with currently having HbA1c values between 6.5% to 8.0 gm%. 4) Subjects currently managing T2DM by dietary or herbal supplements and exercise only for at least 8 weeks prior to screening for Group 1.\n\n  5\\) Subjects currently managing T2DM by 500 mg Metformin dose for Group 2. 6) Subjects having prescription or diabetes related laboratory reports at the time of screening.\n\n  7\\) Subjects willing to come in fasting state for every study visit. 8) Subjects are willing to give written informed consent and are willing to come for regular follow up.\n\n  9\\) Subjects who commit not to use other medications other than the allocated test treatment for the entire duration of the study.\n\n  10\\) Subjects who have note participated in any other similar clinical study in last 3 months.\n\n  11\\) Willing to use test treatment throughout the study period.\n\nExclusion Criteria:\n\n* 1\\) Subjects diagnosed with other types of Diabetes like T1DM or specific type of DM (i.e., pancreatic injury induced DM, diabetes mellitus caused by Cushing's syndrome or acromegaly, Latent Autoimmune Diabetes in Adults (LADA), Maturing Onset diabetes of the young (MODY) etc.) 2) Subjects with any end organ damage due to diabetes (including microvascular complications like retinopathy, nephropathy and macrovascular complications like ischemic heart disease, peripheral vascular disease and cerebrovascular disease resulting in organ and tissue damage) within 6 months prior to screening.\n\n  3\\) Subjects taking any weight loss medication or dietary supplements, have participated in a weight loss program within 4 weeks prior to screening.\n\n  4\\) Subjects taking any glucose modifying medication like Sulfonylureas, Biguanides (Except 500 mg Metformin), Meglitinides, Thiazolidinediones, DPP-4 inhibitors, GLP-1 agonist, SGLT2 inhibitor, Alpha-glycosidase inhibitors or any other within 8 weeks prior to screening.\n\n  5\\) Subjects having history of drug or alcohol use. 6) Subjects having history of smoking or currently smoking or using any form of smokeless tobacco.\n\n  7\\) Subjects who have deviations in the laboratory reports which could warrant exclusion from the study, as per investigator's opinion.\n\n  8\\) Individuals with uncontrolled hypertension defined as Systolic blood pressure ≥ 140 mm Hg and\u002For Diastolic blood pressure ≥ 90 mm Hg with or without anti-hypertensives.\n\n  9\\) Subjects who are hypersensitive to any of the components of the treatment. 10) Subjects who have planned major changes in the lifestyle (i.e., diet, dieting, exercise level, significant travel) during the duration of the study.\n\n  11\\) Participation in a study of any other treatment within 90 days prior to the screening.\n\n  12\\) Pregnant or breastfeeding or planning to become pregnant during the study period.",{"count":119,"type":22},14,[94],"This is a Proof-of-Science, exploratory, prospective, single-treatment, two-group, clinical safety, efficacy and tolerability study of herbal based Sugar support effervescent tablets on the patients with Type 2 Diabetes Mellitus.",[31],"2026-02-03",{"date":125,"type":47},"2026-02-05",{"date":127,"type":47},"2025-08-25",{"date":129,"type":22},"2026-03-14",{"name":131,"class":110},"NovoBliss Research Pvt Ltd",{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":81},"100615715","increasing-the-uptake-of-dsmes-program-and-addressing-social-needs-in-low-income-vulnerable-immigrants-100615715","NCT07296211","INcreasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income VulneRablE Immigrants","Increasing the Uptake of DSMES Program and Addressing Social Needs in Low-Income Vulnerable Immigrants","INSPIRE","Inclusion Criteria:\n\nTo be eligible to participate in this study, the patient participant must meet all the following criteria:\n\n1. ≥18 years old and ≤ 70 years old\n2. Self-identify their primary language as English, Mandarin, Cantonese, or Spanish\n3. Diagnosed with T2DM\n4. Has their most recent HbA1c ≥8% or have a new diagnosis of T2DM within the past 6 months\n\nFor patient participants randomized to the mHealth cohort, they must meet the below inclusion criteria\n\n1\\. Willing to receive text messages with brief videos regarding T2DM management\n\nExclusion Criteria:\n\n1. Unable or unwilling to provide informed consent\n2. Unable to participate meaningfully in the intervention (e.g. uncorrected sight and hearing impairment)\n3. Is currently pregnant (Pregnant women will be excluded from this study because they may have special dietary restrictions that are not covered by our DSMES videos for the general population with T2DM.)","70 Years",{"count":142,"type":22},480,[94],"The purpose of this study is to evaluate a multi-level approach to improve diabetes control via access to social service supports and online, culturally-tailored diabetes self-management education and support (DSMES) videos among a community of primarily Chinese and Latino\u002Fa immigrants. The study aims to assess patient uptake, provider adoption, and INSPIRE program acceptability, appropriateness, feasibility, fidelity, penetration\u002Freach, and maintenance.",[31],[147,148],"T2DM","Diabetes","2025-12-09",{"date":151,"type":47},"2025-12-22",{"date":153,"type":22},"2026-01",{"date":155,"type":22},"2029-06",{"name":157,"class":110},"NYU Langone Health",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":165,"enrollmentInfo":166,"targetDuration":4,"studyType":168,"phases":4,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":4},"100605995","diet-and-progression-of-ckd-in-patients-with-type-2-diabetes-mellitus-100605995","NCT07169786","Diet and Progression of CKD in Patients With Type 2 Diabetes Mellitus","The Association Between Dietary Pattern and the Progression of Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* • Adults aged above 18 years\n\n  * Diagnosed with type 2 diabetes mellitus according to ADA criteria.\n  * Diagnosed with chronic kidney disease stages 1-4 (eGFR 15-90 mL\u002Fmin\u002F1.73 m²) for at least 3 months.\n  * Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* • Patients with end-stage renal disease (CKD stage 5 or on dialysis).\n\n  * History of kidney transplantation.\n  * Acute kidney injury within the past 3 months.\n  * Pregnant or lactating women.\n  * Patients with severe comorbid conditions (e.g., active malignancy, severe heart failure).\n  * Use of medications known to significantly affect renal function (other than standard antihypertensive or antidiabetic therapy).","90 Years",{"count":167,"type":22},160,"OBSERVATIONAL","The aim of this study is to investigate the relationship between dietary patterns and the progression of chronic kidney disease (CKD) in patients with type 2 diabetes mellitus.",[171,172,31],"CKD Stage 1-4","Diet Pattern Analysis","2025-09-10",{"date":175,"type":47},"2025-09-12",{"date":177,"type":22},"2025-10",{"date":179,"type":22},"2028-12",{"name":181,"class":110},"Mariam Emeel Haleem Naseem",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":16,"sex":17,"minAge":189,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":81},"100596385","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-dapagliflozin-linagliptin-and-metformin-in-healthy-adults-fed-state-study-100596385","NCT07044765","A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults: Fed State Study","An Open-label, 2-arm, Single-sequence, Fed, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects","Inclusion Criteria:\n\n* Healthy adult volunteers aged 19 to 50 years at the time of screening.\n* Body mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\n  * Male subjects must weigh ≥50 kg.\n  * Female subjects must weigh ≥45 kg.\n* No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.\n* Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.\n* Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 7 days after the last dose, and agrees not to donate sperm or eggs during this period.\n* Able and willing to provide written informed consent after receiving a full explanation of the study.\n\nExclusion Criteria:\n\n* Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.\n* Participation in any clinical trial involving investigational products within 6 months prior to the first dose.\n* Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.\n* History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).\n* History of excessive alcohol consumption within 1 month prior to the first dose:\n\n  * \\>21 drinks\u002Fweek for males, \\>14 drinks\u002Fweek for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)\n* Known hypersensitivity to any component of the investigational product.\n* Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:\n\n  * Moderate to severe renal impairment (eGFR or creatinine clearance \\\u003C45 mL\u002Fmin)\n  * Dialysis\n  * Acute or unstable heart failure\n  * Acute myocardial infarction, septicemia, or shock\n  * Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis\n  * Major surgery planned during the study (except minor procedures not affecting food or fluid intake)\n  * Severe infections, trauma, or nutritional deficiencies\n* Positive pregnancy test or currently breastfeeding (for female subjects).\n* History of significant psychiatric illness.\n* Determined by the investigator to be unsuitable for the study for any other reason.","19 Years","50 Years",{"count":192,"type":22},32,[67],"To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults after taking the drugs with food (fed state).",[31],"2025-06-26",{"date":198,"type":47},"2025-07-01",{"date":200,"type":22},"2025-08",{"date":202,"type":22},"2025-11",{"name":204,"class":54},"AJU Pharm Co., Ltd.",{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":16,"sex":17,"minAge":189,"maxAge":190,"enrollmentInfo":212,"targetDuration":4,"studyType":23,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":221,"leadSponsor":222,"locationsCount":81},"100595617","phase-1-a-study-to-evaluate-the-safety-and-pharmacokinetics-of-dapagliflozin-linagliptin-and-metformin-in-healthy-adults-100595617","NCT07034781","A Study to Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults","An Open-label, 2-arm, Single-sequence, Single Oral Dosing, Crossover Clinical Trial to Evaluate Safety and the Pharmacokinetics Between Dapagliflozin, Linagliptin and Metformin in Healthy Adult Subjects","Inclusion Criteria:\n\n* Healthy adult volunteers aged 19 to 50 years at the time of screening.\n* Body mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive.\n\n  * Male subjects must weigh ≥50 kg.\n  * Female subjects must weigh ≥45 kg.\n* No clinically significant congenital or chronic diseases requiring treatment, based on medical history and physical examination.\n* Clinically acceptable results from laboratory tests (e.g., hematology, biochemistry, serology, urinalysis) and electrocardiogram (ECG) at screening, as determined by the investigator.\n* Willing to use medically accepted contraception (excluding hormonal methods) from the first dose until 50 days after the last dose, and agrees not to donate sperm or eggs during this period.\n* Able and willing to provide written informed consent after receiving a full explanation of the study.\n\nExclusion Criteria:\n\n* Use of drugs known to induce or inhibit drug-metabolizing enzymes within 30 days prior to the first dose, or any medication likely to interfere with the study within 10 days prior to dosing.\n* Participation in any clinical trial involving investigational products within 6 months prior to the first dose.\n* Whole blood donation within 8 weeks, or component blood donation within 2 weeks prior to the first dose.\n* History of gastrointestinal surgery that may affect drug absorption (excluding appendectomy and hernia repair).\n* History of excessive alcohol consumption within 1 month prior to the first dose:\n\n  * \\>21 drinks\u002Fweek for males, \\>14 drinks\u002Fweek for females (1 drink = 50 mL soju, 30 mL whiskey, or 250 mL beer)\n* Known hypersensitivity to any component of the investigational product.\n* Clinically significant renal, hepatic, cardiovascular, respiratory, metabolic, or infectious diseases, including but not limited to:\n\n  * Moderate to severe renal impairment (eGFR or creatinine clearance \\\u003C45 mL\u002Fmin)\n  * Dialysis\n  * Acute or unstable heart failure\n  * Acute myocardial infarction, septicemia, or shock\n  * Type 1 diabetes, metabolic acidosis, or history of diabetic ketoacidosis\n  * Major surgery planned during the study (except minor procedures not affecting food or fluid intake)\n  * Severe infections, trauma, or nutritional deficiencies\n* Positive pregnancy test or currently breastfeeding (for female subjects).\n* History of significant psychiatric illness.\n* Determined by the investigator to be unsuitable for the study for any other reason.",{"count":213,"type":22},50,[67],"To Evaluate the Safety and Pharmacokinetics of Dapagliflozin, Linagliptin, and Metformin in Healthy Adults",[31],"2025-06-20",{"date":219,"type":47},"2025-06-24",{"date":200,"type":22},{"date":202,"type":22},{"name":204,"class":54},{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":23,"phases":232,"briefSummary":233,"conditions":234,"keywords":240,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":81},"100551808","effects-of-a-health-intervention-on-fear-of-hypoglycemia-100551808","NCT06464900","Effects of a Health Intervention on Fear of Hypoglycemia","Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Randomized Controlled Study","Inclusion Criteria:\n\n* Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus;\n* Age ≥18 years;\n* Duration of diabetes mellitus ≥1 year;\n* FoH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS);\n* Patients who have the ability to listen, read, write, walk, and cooperate to complete the study;\n* Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate;\n* Voluntarily participate in this study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc;\n* Patients with comorbid psychiatric diseases or taking psychotropic drugs;\n* Patients who have recently or are participating in other studies on similar topics.",{"count":231,"type":22},90,[94],"To examine the effects of a health Education Intervention based on the Behaviour Change Wheel (BCW) theory on fear of hypoglycemia and relevant outcomes of type 2 diabetic patients.",[235,236,237,238,239,31],"Health-Related Behavior","Health Education","Fear of Hypoglycemia","Impaired Awareness of Hypoglycemia","Self-Management",[241,242,243,244,245,246,247],"Behaviour Change Wheel","Health educational intervention","Fear of hypoglycaemic","Impaired awareness of hypoglycaemia","Medical support","Self-management attitude","Type 2 diabetes mellitus","2024-07-07",{"date":250,"type":47},"2024-07-09",{"date":252,"type":22},"2024-07",{"date":254,"type":22},"2025-01",{"name":256,"class":110},"Yangzhou University",{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":16,"sex":17,"minAge":264,"maxAge":140,"enrollmentInfo":265,"targetDuration":4,"studyType":23,"phases":267,"briefSummary":268,"conditions":269,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":280},"100554269","a-study-to-assess-effect-of-glucocil-on-metabolic-health-in-individuals-with-prediabetes-and-type-2-diabetes-mellitus-100554269","NCT06496893","A Study to Assess Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.","A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Glucocil® on Metabolic Health in Individuals With Prediabetes and Type 2 Diabetes Mellitus.","Inclusion Criteria:\n\n1. Males and females of age more than equal to 30 years and less than equal to 70 years.\n2. Body mass index within 30 kg\u002Fm2 and 35 kg\u002Fm2 (both values included) with waist circumference above 40 inches (men) or 35 inches (women).\n3. Cohort 1 (Only for prediabetes individuals)- Individuals diagnosed with prediabetes with OGTT (140 mg\u002FdL to 199 mg\u002FdL); HbA1c (5.7% to 6.9%) and fasting blood glucose level (between 100 mg\u002FdL to 125 mg\u002FdL).\n4. Cohort 2 (T2DM)- Individuals newly diagnosed with Type 2 diabetes mellitus with HbA1c between 7% and 9% (both values included) and fasting blood glucose level in between 126 to 180 mg\u002FdL.\n5. Triglycerides between 150 mg\u002FdL and 299 mg\u002FdL (both values inclusive) and\u002For Low-Density Lipoprotein (LDL) in between 130 mg\u002FdL and 189 mg\u002FdL (both values inclusive).\n6. Individuals having non-vegetarian diet for at least 2 days a week.\n7. Non-smoker.\n8. Individuals who are willing to not change their physical activity levels throughout the study period.\n9. Individuals willing to complete all study-related questionnaires and to complete all clinical study visits.\n10. Individuals ready to give voluntary, written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Individuals who are exclusively vegetarians diet.\n2. Individuals with Type 1 diabetes mellitus.\n3. Individuals with Type 2 diabetes mellitus on medication.\n4. Individuals with any other endocrine disorder.\n5. Individuals who are currently on diuretics or thyroid supplements\n6. Individuals on lipid-lowering therapies.\n7. Individuals with uncontrolled hypertenstion as assessed by systolic over diastolic blood pressure (≥ 140\u002F90 mmHg).\n8. Individuals who are currently on antihypertensive medication.\n9. Individuals with cardiac arrhythmia, impaired hepatic or renal function\n10. Individuals having heart failure, coronary artery disease, hyperthyroidism, hypothyroidism, cancer or mental disease or any other serious disease requiring active treatment.\n11. History of malignancy or stroke.\n12. Chronic alcoholism: History and\u002For current cases of chronic alcohol consumption or heavy drinkers as defined by i.For men consuming more than 4 drinks on any day or more than 14 drinks\u002Fweek ii. For women, consuming more than 3 drinks on any day or more than 7 drinks\u002Fweek\n13. Individuals taking concomitant medication known to alter blood sugar.\n14. Individuals having treatment with herbal or any other supplements.\n15. Any condition or abnormality that would compromise the safety of the individuals or the quality of the study data.\n16. Use of another investigational product within 3 months of the screening visit.\n17. Females who are lactating, pregnant or planning to be pregnant or taking any oral contraceptives","30 Years",{"count":266,"type":22},100,[94],"A randomized, double-blind, placebo-controlled study to assess the effect of Glucocil® on metabolic health in individuals with prediabetes and Type 2 Diabetes Mellitus.",[270,31],"Pre Diabetes","2024-07-03",{"date":273,"type":47},"2024-07-11",{"date":275,"type":22},"2024-07-25",{"date":277,"type":22},"2024-12-30",{"name":279,"class":54},"Vedic Lifesciences Pvt. Ltd.",5,{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":287,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":289,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":291,"briefSummary":293,"conditions":294,"keywords":296,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":81},"100550650","phase-4-effect-of-henagliflozein-on-hepatic-fat-content-in-patients-with-t2dm-and-nafld-100550650","NCT06449833","Effect of Henagliflozein on Hepatic Fat Content in Patients With T2DM and NAFLD","Effect of Henagliflozein on Hepatic Fat Content in Patients With Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Multicenter, Randomized, Controlled Clinical Trial","HHTN","Inclusion Criteria:\n\n1. Patients diagnosed with type 2 diabetes within 5 years (According to the diagnostic criteria of WHO Diabetes Classification 2019)\n2. Patients who are aware of the purpose of the trail, willing to participate in the trial and sign informed consent forms, and comply with all requirements (including those during follow-up and evaluation investigations)\n3. Well-controlled blood glucose through diet and exercise intervention, or stable treatment with 1 or 2 types of hypoglycemic drugs (metformin, sulfonylurea, glinide, α-glycosidase inhibitor ) for at least 8 weeks with a half or full recommended maximum tolerated dose in instructions.\n4. HbA1c: 7.0%-8.5%\n5. Patients diagnosed with non-alcoholic fatty liver disease (According to the diagnostic criteria of Guidelines for Diagnosis and Treatment of Non-alcoholic Fatty Liver Disease 2010)\n\nExclusion Criteria:\n\n1. Patients with type 1 diabetes, gestational diabetes or other special types of diabetes;\n2. Patients with any acute, chronic complication or risk that may cause greater adverse effects than benefits through the trial; or receiving other treatment currently that may affect subjects' compliance or the objectivity of the end point of this trial; (1)Patients with serious acute complications of diabetes in the past 6 months (Eg. diabetic ketoacidosis, hyperosmotic hyperglycemia coma); (2)Patients with unstable proliferative retinopathy or maculopathy,severe diabetic neuropathy, intermittent claudication or diabetic foot in the past 6 months; (3)Patients with serious liver dysfunction and chronic kidney disease or disease of other systems (Eg. Acute and chronic pancreatitis, liver cirrhosis, nephrotic syndrome ect. ); and those who do not meet the requirements after being evaluated by professionals; (4)Have a history of myocardial infarction, unstable angina pectoris, stroke or transient ischemic attack, or underwent coronary angioplasty, percutaneous coronary stenting or coronary artery bypass grafting 6 months before the screening; or screening for congestive heart failure (New York Heart Association NYHA grade III and IV), unstable or acute congestive heart failure, or persistent arrhythmias believed to be life-threatening within the first 6 months of the trail; (5)Have a history of hemorrhagic stroke or ischemic stroke in the past 6 months, and was evaluated by the researchers as not suitable to participate in this clinical trial; (6)Have a history of hypertension and was not effectively controlled before screening: systolic blood pressure (SBP) ≥ 160mmHg and \u002F or diastolic blood pressure (DBP) ≥ 100mmHg;\n3. Have a history of other endocrine system diseases which affect glucose and lipid metabolism or have an effect on the body weight, such as: multiple endocrine adenomatosis, acromegaly, Cushing syndrome, hyperthyroidism;\n4. Have a history of malignant tumour within 5 years before screening, except for local basal cell carcinoma of the skin after treatment；\n5. Have a history of severe infection, trauma or major surgery within 3 months;\n6. Have a history of drug abuse with 5 years, including repeated use of dependence-producing drug unrelated to medical purposes, including addictive and habitual drugs leading to physical and psychic dependence;\n7. Have a history of participating any intervention drug or instrumental clinical trial 3 months before screening;\n8. Have a history of severe anemia or need regular blood transfusion treatment;\n9. Have a history of any medication or treatment below:\n\n(1)Using drugs that may cause weight change 90 days before screening, including diuretics, weight-loss drug etc.; (2)Using drugs that may affect blood glucose for \\>1 week within 12 weeks, such as oral\u002Fintravenous glucocorticoid, growth hormone, estrogen\u002Fprogesterone, high-dose diuretics, antipsychotic drugs, etc., but low-dose diuretics for antihypertensive purposes (hydrochlorothiazide \\\u003C 25mg\u002Fd, indapamide \\\u003C 1.5 mg\u002Fd) are not included in this restriction; (3)Had bariatric sugery or planning to have bariatric surgery; 10.The laboratory results of patients meet the following standards:\n\n1. AlanineAminotransferase(ALT)and\u002Foraspartateaminotransferase(AST) higher than 5 times of the upper limit of the normal value.\n2. Glomerular Filtration Rate (eGFR) estimated by CKD-EPI formula \\\u003C 40mL\u002F (min·1.73m2); 11.Patients are currently pregnant, breastfeeding or planning a pregnancy; 12.Have a history of infectious diseases such as hepatitis B (HBs-Ag), hepatitis C (HCV-Ab), pulmonary tuberculosis or sexually transmitted active diseases such as HIV and syphilis; 13.Have a history of using anti-NASH drugs (vitamin E, ursodeoxycholic acid, s-Adenosylmethionine, betaine, silymarin, gemdibrozil, anti-TNF therapy, probiotics, ect.) within 3 months before random grouping; 14.Having structural and functional genitourinary abnormalities prone to cause genitourinary infection; 15.Patients with abnormal hematologic system or any diseases that may cause hemolysis or unstable erythrocyte; 16.Have a history of using immunomodulators, such as biological agents, cyclophosphamide, cyclosporine, etc.; 17.Patients with MRI incompatible metal or magnetic implant, device or materials.","75 Years",{"count":266,"type":22},[292],"PHASE4","This study focuses on the effects of Henagliflozein on hepatic fat content in patients with type 2 diabetes mellitus (DM) and nonalcoholic fatty liver disease (NAFLD). Sponsored by Zhujiang Hospital of Southern Medical University, this study is a multi-center, randomized, controlled clinical trial, aiming at exploring the difference in the reduction of liver fat content in the subjects compared with the control group after 24 weeks of treatment. Subjects from different medical centers diagnosed with T2DM and NAFLD will be randomly assigned to the treatment or control group in a 1:1 ratio, and subsequently initiate the intervention period of 24 weeks. In this trial, patients will be treated with 10 mg of Henagliflozein + metformin and 5 mg of Linagliptin + metformin as control, and the dose of metformin will be customized at 500-1500mg according to their individual blood glucose level. The check-points are set at the 8th, 16th and 24th week of the follow-up after the treatment, and nutritionists are available to provide dietary and exercise guidance.",[31,295],"Nonalcoholic Fatty Liver Disease",[297,298,299,300,301],"Type 2 Diabetes Mellitus","Nonalcoholic fatty liver disease","Hepatic Fat Content","Henagliflozein","liver function","2024-06-03",{"date":304,"type":47},"2024-06-10",{"date":306,"type":22},"2024-06",{"date":308,"type":22},"2026-11",{"name":310,"class":110},"Zhujiang Hospital"]