Status:
COMPLETED
HSK7653 in Chinese Patients with Impaired Glucose Tolerance
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
Impaired Glucose Tolerance
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
Eligibility Criteria
Inclusion
- Impaired glucose tolerance;
- BMI (Body Mass Index) in the range of ≥ 18.0 kg/m2 to ≤ 35.0 kg/m2 at screening;
Exclusion
- 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.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT04727580
Start Date
March 29 2021
End Date
June 29 2022
Last Update
November 25 2024
Active Locations (1)
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1
Emergency General Hospital
Beijing, Beijing Municipality, China, 100028