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Completed

NCT Number: NCT04727580

HSK7653 in Chinese Patients with Impaired Glucose Tolerance

This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.

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Key information

Conditions

Impaired Glucose Tolerance Diabetes Mellitus Endocrine System Diseases Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Emergency General Hospital

Beijing, Beijing Municipality, 100028, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Impaired glucose tolerance;
  • BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;

Exclusion criteria

  • History of diabetes mellitus;
  • History of severe endocrine disease, uncured cancer, acute pancreatitis prior to informed consent;
  • Current uncontrolled hypertension, serious nephropathy prior to informed consent;
  • Serious Heart Failure (class III-IV of the New York Heart Association functional classification), serious Arrhythmia, and Stroke within 6 months prior to informed consent;
  • Serious gastrointestinal disease within 2 weeks prior to informed consent;
  • Serious infection, trauma, and surgery within 3 months prior to informed consent;
  • History of treatment with Glucagon-like peptide 1(GLP-1) analogues, Dipeptidyl-Peptidase 4(DPP-IV) inhibitor;
  • Treatment with drugs that affect glucose metabolism within 8 weeks prior to informed consent;
  • Hemoglobin (HGB) < 10.0 g/dL(100 g/L);
  • Alcohol abuse within 6 months or drug abuse history within 5 years prior to informed consent;
  • Active infectious diseases;
  • Participation in another trial with an investigational drug or instrument within 3 months prior to informed consent;
  • Women who are nursing or pregnant, or subjects with birth plans;
  • Other protocol-defined inclusion/exclusion criteria.

Treatment and study plan

HSK7653 10mg Q2W

Drug

HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12

HSK7653 25mg Q2W

Drug

HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Placebo

Drug

Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Primary outcomes

  1. Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

    Time frame: Baseline and Week 12

    Plasma glucose AUC 0-3 hours for MTT was measured at Baseline (Week 0) and at Week 12. After fasting for ≥8 hours, blood samples for glucose measurement were drawn at 0 minutes (at standard meal loading), 30 minutes, 60 minutes, 90 minutes, 120 minutes, and 180 minutes. At Week 12, participants received study drug or placebo 50 minutes prior to consuming a standard meal.

Secondary outcomes

  1. Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

    Time frame: Baseline and Week 12

  2. Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12

    Time frame: Baseline and Week 12

  3. Change From Baseline in Fasting Glucose at Week 12

    Time frame: Baseline and Week 12

  4. Change From Baseline in Fasting Insulin at Week 12

    Time frame: Baseline and Week 12

  5. Change From Baseline in Fasting C-peptide at Week 12

    Time frame: Baseline and Week 12

  6. Change From Baseline in HOMA-IS at Week 12

    Time frame: Baseline and Week 12

  7. Change From Baseline in HOMA-β at Week 12

    Time frame: Baseline and Week 12

  8. Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12

    Time frame: Baseline and Week 12

  9. Change From Baseline in Plasma Glucose Area Under the Curve 0 to 3 Hours (AUC 0-3 Hrs) for Oral Glucose Tolerance Test (OGTT) at Week 10

    Time frame: Baseline and Week 10

  10. Incidence of Treatment-Emergent Adverse Events

    Time frame: Baseline and Week 12

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Clinical Trial to Study the Efficacy and Safety of HSK7653 in Chinese Patients with Impaired Glucose Tolerance

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2021
Registry last updated
Nov 25, 2024

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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