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| Name | Class |
|---|---|
| Shanghai 6th People's Hospital | OTHER |
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A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supaglutide (Part A) | Experimental | Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients. |
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| Placebo(Part A) | Placebo Comparator | Placebo administered weekly (or bi-weekly) and SC in T2DM patients. |
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| Supaglutide (Part B) | Experimental | Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients. |
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| Placebo (Part B) | Placebo Comparator | Placebo administered weekly (or bi-weekly) and SC in T2DM patients. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supaglutide | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, 7 weeks, 17weeks |
| Adverse Events | Number of Adverse Events | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B |
| Vital Sign | Assessments of Vital Sign | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B |
| Laboratory Tests | Assessments of Laboratory Tests | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B |
| 12-lead ECGs | Assessments of 12-lead ECGs | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B |
| Immunogenicity Tests | Assessments of Immunogenicity Tests | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c <7% | Percentage of Participants Achieving HbA1c Target <7.0% | Baseline, 7 weeks, 17weeks |
| Glycosylated Albumin | Changes from Baseline in Glycosylated Albumin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weiping Jia, Doctor | Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital | Principal Investigator |
| Yuqian Bao, Doctor | Department of Endocrinology and Metabolism, Shanghai Sixth People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Zhongda Hospital of Southeast University | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39961992 | Derived | Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Administered SC |
|
| Baseline, 7 weeks, 17weeks |
| Fasting Blood Glucose | Changes from Baseline in Fasting Blood Glucose | Baseline, 7 weeks, 17weeks |
| Fasting Blood Insulin | Changes from Baseline in Fasting Blood Insulin | Baseline, 7 weeks, 17weeks |
| Fasting Blood C-peptide | Changes from Baseline in Fasting Blood C-peptide | Baseline, 7 weeks, 17weeks |
| Blood Lipid | Changes from Baseline in Blood Lipid | Baseline, 7 weeks, 17weeks |
| Body Weight | Changes from Baseline in Body Weight | Baseline, 7 weeks, 17weeks |
| Pharmacokinetics (PK): Area Under the Curve | Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞) | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A) |
| Pharmacokinetics (PK): t½ of Supaglutide | Terminal Elimination Half-life in Plasma (t½) | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A) |
| PK: Tmax of Supaglutide | Time to Maximum Plasma Concentration (Tmax) | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A) |
| D004700 | Endocrine System Diseases |