A Study of Supaglutide in Chinese Type 2 Diabetes Patients

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Supaglutide; Drug: Placebo

• Registration Number: NCT04314622
• Lead Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-11
• Study First Submitted QC: 2020-03-17
• Study First Posted: 2020-03-19
• Study Start: 2020-04-14
• Primary Completion: 2020-10-25
• Study Completion: 2021-03-16
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-16
• Last Update Posted: 2021-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 Previously completed or withdrawn from this study after providing informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supaglutide (Part A)	Supaglutide	Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.
Placebo(Part A)	Placebo	Placebo administered weekly (or bi-weekly) and SC in T2DM patients.
Supaglutide (Part B)	Supaglutide	Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.
Placebo (Part B)	Placebo	Placebo administered weekly (or bi-weekly) and SC in T2DM patients.

Primary Outcome Measures

Name	Time	Method
Immunogenicity Tests	Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B	Assessments of Immunogenicity Tests
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
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

Secondary Outcome Measures

Name	Time	Method
Fasting Blood Insulin	Baseline, 7 weeks, 17weeks	Changes from Baseline in Fasting Blood Insulin
Fasting Blood C-peptide	Baseline, 7 weeks, 17weeks	Changes from Baseline in Fasting Blood C-peptide
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)
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
Blood Lipid	Baseline, 7 weeks, 17weeks	Changes from Baseline in Blood Lipid
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)
HbA1c <7%	Baseline, 7 weeks, 17weeks	Percentage of Participants Achieving HbA1c Target \<7.0%
Body Weight	Baseline, 7 weeks, 17weeks	Changes from Baseline in Body Weight
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-∞)

Trial Locations

Locations (1)

The Affiliated Zhongda Hospital of Southeast University; 🇨🇳 Nanjing, Jiangsu, China