Impaired Glucose Tolerance
Conditions
Keywords
Impaired Glucose Tolerance, DPP-4 inhibitor, Prediabetes
Brief summary
This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
Interventions
DRUGHSK7653 10mg Q2W
HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12
DRUGHSK7653 25mg Q2W
HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
DRUGPlacebo
Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Plasma Glucose AUC 0-3h for Meal Tolerance Test (MTT) at Week 12 | 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
| Measure | Time frame |
|---|---|
| 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 Insulin AUC 0-3h for Meal Tolerance Test (MTT) 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 |
| Change From Baseline in HOMA-IS at Week 12 | Baseline and Week 12 |
Countries
China
Outcome results
None listed