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This study is being done to evaluate the efficacy, safety of HSK7653 in chinese participants with impaired glucose tolerance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK7653 10 mg | Experimental |
| |
| HSK7653 25 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK7653 10mg Q2W | Drug | HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12 |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency General Hospital | Beijing | Beijing Municipality | 100028 | China |
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| ID | Term |
|---|---|
| D018149 | Glucose Intolerance |
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| HSK7653 25mg Q2W | Drug | HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12 |
|
| Placebo | Drug | Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12 |
|
| 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 |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |