A Study of Supaglutide in Chinese Type 2 Diabetes Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Supaglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have diagnosed with type 2 diabetes for at least 3 months before enrollment. Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only) Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m^2). Exclusion Criteria: Type 1 diabetes (T1D). Evidences of fasting C-peptide levels<0.81 ng/mL. History of trauma, infection or surgery within a month; History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors. Evidence of abnormal thyroid function within 6 months before screening. Positive test results in HBsAg, HCVAB, HIVAB or TPAB. History of serious mental illness. History of drug or alcohol abuse. History of a transplanted organ, acquired or congenital immune system diseases. Allergy to active ingredients or excipients of the test drug. Evidence of abnormal result of laboratory examination according to the judgment of researchers. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study. Previously completed or withdrawn from this study after providing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supaglutide (Part A)<br>Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients. | Drug: Supaglutide<br>* Administered SC<br>* Other names: Diabegone;|
| Placebo Comparator: Placebo(Part A)<br>Placebo administered weekly (or bi-weekly) and SC in T2DM patients. | Drug: Placebo<br>* Administered SC<br>|
| Experimental: Supaglutide (Part B)<br>Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients. | Drug: Supaglutide<br>* Administered SC<br>* Other names: Diabegone;|
| Placebo Comparator: Placebo (Part B)<br>Placebo administered weekly (or bi-weekly) and SC in T2DM patients. | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) |