A Study of Supaglutide in Chinese Type 2 Diabetes Patients

NCT04314622 | Completed Phase 2 DMC

• 1 other identifier: YN011B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• HbA1c <7%

  Baseline, 7 weeks, 17weeks

• Glycosylated Albumin

  Baseline, 7 weeks, 17weeks

• Fasting Blood Glucose

  Baseline, 7 weeks, 17weeks

• Fasting Blood Insulin

  Baseline, 7 weeks, 17weeks

• Fasting Blood C-peptide

  Baseline, 7 weeks, 17weeks

Study Arms (4)

Supaglutide (Part A)

EXPERIMENTAL

Four investigational doses of Supaglutide administered weekly (or bi-weekly) and subcutaneously (SC) in T2DM patients.

Drug: Supaglutide

Placebo(Part A)

PLACEBO COMPARATOR

Placebo administered weekly (or bi-weekly) and SC in T2DM patients.

Drug: Placebo

Supaglutide (Part B)

EXPERIMENTAL

Two investigational doses of Supaglutide administered weekly (or bi-weekly) and SC in T2DM patients.

Drug: Supaglutide

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered weekly (or bi-weekly) and SC in T2DM patients.

Drug: Placebo

Interventions

Supaglutide DRUG

Administered SC

Also known as: Diabegone

Supaglutide (Part A); Supaglutide (Part B)

Placebo DRUG

Administered SC

Placebo (Part B); Placebo(Part A)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.: lead
• Shanghai 6th People's Hospital: collaborator

Study Sites (1)

The Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210000, China

Location

Related Publications (1)

• 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.

  PMID: 39961992 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2020
• First Posted: March 19, 2020
• Study Start: April 14, 2020
• Primary Completion: October 25, 2020
• Study Completion: March 16, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)