HSK7653 in Chinese Patients With Impaired Glucose Tolerance

Impaired Glucose Tolerance Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04727580
• Other study ID #: HSK7653-202
• Status: Recruiting
• Phase: Phase 2
• Start date: March 29, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: April 2021
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Fangqiong Li
• Phone: +8602867258840
• Email: lifangq[@]haisco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 28, 2022
• Est. primary completion date: June 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Drug:
• HSK7653 10mg Q2W
HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12
• HSK7653 25mg Q2W
HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
• Placebo
Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12

Locations

Country	Name	City	State
China	Emergency General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Insulin AUC 0-3h for Meal Tolerance Test (MTT) at Week 12		Baseline and Week 12
Secondary	Change From Baseline in C-peptide AUC 0-3h for Meal Tolerance Test (MTT) at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Fasting Glucose at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Fasting Insulin at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Fasting C-peptide at Week 12		Baseline and Week 12
Secondary	Change From Baseline in HOMA-IS at Week 12		Baseline and Week 12
Secondary	Change From Baseline in HOMA-ß at Week 12		Baseline and Week 12
Secondary	Change From Baseline in Hemoglobin A1c (HbA1c) at Week 12		Baseline and Week 12
Secondary	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
Secondary	Incidence of Treatment-Emergent Adverse Events		Baseline and Week 12