HSK7653 in Chinese Patients with Impaired Glucose Tolerance

Haisco Pharmaceutical Group Co., Ltd.99 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Impaired Glucose Tolerance

Interventions

HSK7653 10mg Q2WDRUG

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

HSK7653 25mg Q2WDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Emergency General Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.