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Completed

NCT Number: NCT04314622

A Study of Supaglutide in Chinese Type 2 Diabetes Patients

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Affiliated Zhongda Hospital of Southeast University

Nanjing, Jiangsu, 210000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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  • Previously completed or withdrawn from this study after providing informed consent.

Treatment and study plan

Supaglutide

Drug

Administered SC

Other names: Diabegone

Placebo

Drug

Administered SC

Primary outcomes

  1. HbA1c

    Time frame: Baseline, 7 weeks, 17weeks

    Change from Baseline in Hemoglobin A1c (HbA1c)

  2. Adverse Events

    Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

    Number of Adverse Events

  3. Vital Sign

    Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

    Assessments of Vital Sign

  4. Laboratory Tests

    Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

    Assessments of Laboratory Tests

  5. 12-lead ECGs

    Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

    Assessments of 12-lead ECGs

  6. Immunogenicity Tests

    Time frame: Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B

    Assessments of Immunogenicity Tests

Secondary outcomes

  1. HbA1c <7%

    Time frame: Baseline, 7 weeks, 17weeks

    Percentage of Participants Achieving HbA1c Target <7.0%

  2. Glycosylated Albumin

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Glycosylated Albumin

  3. Fasting Blood Glucose

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Fasting Blood Glucose

  4. Fasting Blood Insulin

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Fasting Blood Insulin

  5. Fasting Blood C-peptide

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Fasting Blood C-peptide

  6. Blood Lipid

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Blood Lipid

  7. Body Weight

    Time frame: Baseline, 7 weeks, 17weeks

    Changes from Baseline in Body Weight

  8. Pharmacokinetics (PK): Area Under the Curve

    Time frame: 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-∞)

  9. Pharmacokinetics (PK): t½ of Supaglutide

    Time frame: 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)

  10. PK: Tmax of Supaglutide

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Shanghai Yinnuo Pharmaceutical Technology Co., Ltd.

Other

Collaborators

  • Shanghai 6th People's Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Mar 19, 2020
Registry last updated
Sep 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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