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This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the efficacy and safety of HS-20094 injection in subjects with type 2 diabetes who have inadequate glycemic control with diet and exercise alone. The primary objective of this study is to evaluate the effectiveness of HS-20094 compared to placebo in controlling blood glucose levels after 44 weeks and 52 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental |
| |
| Group B | Placebo Comparator |
| |
| Group C | Experimental |
| |
| Group D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 Injection | Drug | HS-20094 injected subcutaneously once weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change from baseline in HbA1c after 44 weeks of treatment | Week 0 to Week 44 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | Proportion of subjects with HbA1c<7.0% and ≤6.5% after 44 weeks of treatment | Week 0 to Week 44 |
| Change in FPG | Change from baseline in FPG after 44 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China |
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| HS-20094 Placebo Injection |
| Drug |
HS-20094 Placebo injected subcutaneously once weekly |
|
| HS-20094 Injection | Drug | HS-20094 injected subcutaneously once weekly |
|
| HS-20094 Placebo Injection | Drug | HS-20094 Placebo injected subcutaneously once weekly |
|
| Week 0 to Week 44 |
| Change in body weight | Change from baseline in Change in body weight after 44 weeks of treatment | Week 0 to Week 44 |
| Proportion of subjects with weight loss ≥5% and ≥10% | Proportion of subjects with weight loss ≥5% and ≥10% after 44 weeks of treatment | Week 0 to Week 44 |
| Change in HbA1c | Change from baseline in HbA1c after 52 weeks of treatment | Week 0 to Week 52 |
| Proportion of subjects with HbA1c<7.0% and ≤6.5% | Proportion of subjects with HbA1c<7.0% and ≤6.5% after 52 weeks of treatment | Week 0 to Week 52 |
| Change in FPG | Change from baseline in FPG after 52 weeks of treatment | Week 0 to Week 52 |
| Change in body weight | Change from baseline in Change in body weight after 52 weeks of treatment | Week 0 to Week 52 |
| Proportion of subjects with weight loss ≥5% and ≥10% | Proportion of subjects with weight loss ≥5% and ≥10% after 52 weeks of treatment | Week 0 to Week 52 |
| Incidence and severity of adverse events | Severity (mild, moderate and severe) is assessed by investigator | Week 0 to Week 52+4 weeks follow-up |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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