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This study aims to evaluate the efficacy and safety of DBPR108 tablets in combination with metformin hydrochloride in the treatment of type 2 diabetes mellitus. A total of 210 subjects will be randomly assigned in a ratio of 2:1 to receive metformin hydrochloride plus DBPR108 or metformin hydrochloride plus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin hydrochloride+DBPR108 | Experimental | metformin hydrochloride 500 mg+DBPR108 100 mg |
|
| metformin hydrochloride+placepo | Placebo Comparator | metformin hydrochloride 500 mg+placebo 100 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DBPR108 | Drug | DBPR108: 100 mg, once daily for 24 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (%) from baseline to week 24 | The change of HbA1c from baseline to 24 weeks compared with metformin hydrochloride + placebo | baseline, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of HbA1c ≤ 6.5% | Proportion of patients achieving HbA1c ≤ 6.5% at week 24 | 24 weeks |
| Percentage of HbA1c ≤ 7% | Proportion of patients achieving HbA1c ≤ 7% at week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kun Lou | Department of medicine, CSPC clinical development division | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 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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| ID | Term |
|---|---|
| C000718187 | DBPR108 |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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| metformin hydrochloride |
| Drug |
metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks. |
|
| placepo | Drug | placebo:100 mg, once daily for 24 weeks. |
|
| 24 weeks |
| Change in HbA1c (%) from baseline to week 12 | The change of HbA1c from baseline to 12 weeks compared with metformin hydrochloride + placebo | baseline, 12 weeks |
| Change in fasting plasma glucose (FPG) from baseline to week 12 and week 24 | The change in FPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo | Baseline, 12 weeks and 24 weeks |
| Change in 2h-postprandial plasma glucose (2h-PPG) from baseline to week 12 and week 24 | The change in 2h-PPG from baseline to week 12 and week 24 compared with metformin hydrochloride + placebo | Baseline, 12 weeks and 24 weeks |
| Change in body weight from baseline to week 12 and week 24 | The change in body weight from baseline to week 12 and week 24 compared with metformin hydrochloride +placebo | Baseline, 12 weeks and 24 weeks |
| D004700 | Endocrine System Diseases |