A Study of Supaglutide in Chinese Type 2 Diabetes Patients

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

A study on the safety, efficacy, pharmacokinetics and pharmacodynamics of Supaglutide dosing weekly and bi-weekly in patients with type 2 diabetes mellitus.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: Supaglutide

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210000
      • The Affiliated Zhongda Hospital of Southeast University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Previously completed or withdrawn from this study after providing informed consent.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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.
• Collaborators: Shanghai 6th People's Hospital
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2020
• Primary Completion (Actual): October 25, 2020
• Study Completion (Actual): March 16, 2021

Study Registration Dates

• First Submitted: March 11, 2020
• First Submitted That Met QC Criteria: March 17, 2020
• First Posted (Actual): March 19, 2020

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: YN011B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No