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The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20004 or placebo treatment (Low dose) | Other | HS-20004 or placebo SC once daily (Low dose) |
|
| HS-20004 or placebo treatment (median dose 1) | Other | HS-20004 or placebo SC once daily (median dose 1) |
|
| HS-20004 or placebo treatment (median dose 2) | Other | HS-20004 or placebo SC once daily (median dose 2) |
|
| HS-20004 or placebo treatment (high dose) | Other | HS-20004 or placebo SC once daily (high dose) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20004 | Drug | treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product | 16 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | Estimated mean change from baseline in FPG at week 16. | 16 weeks treatment |
| Change in Body Weight | Estimated mean change from baseline in Body Weigh at week 16. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower hospital The Affiliated Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 16 weeks treatment |
| D004700 | Endocrine System Diseases |