Diabetes Mellitus, Type 2
Conditions
Brief summary
A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.
Interventions
DRUGSupaglutide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Shanghai 6th People's Hospital
Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Have diagnosed with type 2 diabetes for at least 3 months before enrollment. 2. 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) 3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory. 4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m\^2).
Exclusion criteria
1. Type 1 diabetes (T1D). 2. Evidences of fasting C-peptide levels\<0.81 ng/mL. 3. History of trauma, infection or surgery within a month; 4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months. 5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors. 6. Evidence of abnormal thyroid function within 6 months before screening. 7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB. 8. History of serious mental illness. 9. History of drug or alcohol abuse. 10. History of a transplanted organ, acquired or congenital immune system diseases. 11. Allergy to active ingredients or excipients of the test drug. 12. Evidence of abnormal result of laboratory examination according to the judgment of researchers. 13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study. 14. Previously completed or withdrawn from this study after providing informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | Baseline, 7 weeks, 17weeks | Change from Baseline in Hemoglobin A1c (HbA1c) |
| Adverse Events | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Number of Adverse Events |
| Vital Sign | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Assessments of Vital Sign |
| Laboratory Tests | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Assessments of Laboratory Tests |
| 12-lead ECGs | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Assessments of 12-lead ECGs |
| Immunogenicity Tests | Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B | Assessments of Immunogenicity Tests |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting Blood C-peptide | Baseline, 7 weeks, 17weeks | Changes from Baseline in Fasting Blood C-peptide |
| Blood Lipid | Baseline, 7 weeks, 17weeks | Changes from Baseline in Blood Lipid |
| Body Weight | Baseline, 7 weeks, 17weeks | Changes from Baseline in Body Weight |
| HbA1c <7% | Baseline, 7 weeks, 17weeks | Percentage of Participants Achieving HbA1c Target \<7.0% |
| Glycosylated Albumin | Baseline, 7 weeks, 17weeks | Changes from Baseline in Glycosylated Albumin |
| Fasting Blood Glucose | Baseline, 7 weeks, 17weeks | Changes from Baseline in Fasting Blood Glucose |
| Fasting Blood Insulin | Baseline, 7 weeks, 17weeks | Changes from Baseline in Fasting Blood Insulin |
| Pharmacokinetics (PK): Area Under the Curve | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A) | Area Under the Plasma Drug Concentration-Time Curve from Zero to Infinity (AUC0-∞) |
| Pharmacokinetics (PK): t½ of Supaglutide | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A) | Terminal Elimination Half-life in Plasma (t½) |
| PK: Tmax of Supaglutide | Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A) | Time to Maximum Plasma Concentration (Tmax) |
Countries
China
Outcome results
None listed