HSK7653 in Chinese Patients With Impaired Glucose Tolerance

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

Official Title
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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

Conditions
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Impaired Glucose Tolerance

Intervention / Treatment
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* Drug: HSK7653 10mg Q2W
* Drug: HSK7653 25mg Q2W
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSK7653 10 mg<br> | Drug: HSK7653 10mg Q2W<br>* HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12<br>|
| Experimental: HSK7653 25 mg<br> | Drug: HSK7653 25mg Q2W<br>* HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at 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. | Baseline and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in Fasting Glucose at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in Fasting Insulin at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in Fasting C-peptide at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in HOMA-IS at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in HOMA-β at Week 12 |  | Baseline and Week 12 | 
| Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12 |  | Baseline and Week 12 | 
| 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 |  | Baseline and Week 10 | 
| Incidence of Treatment-Emergent Adverse Events |  | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes