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This study is a multicenter, randomized, double-blind, parallel-controlled, phase III clinical trial to evaluate efficacy and safety of the triple combination therapy of prusogliptin, dapagliflozin and metformin in subjects with type 2 diabetes who have inadequate glycemic control on metformin alone.
Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prusogliptin, Dapagliflozin(high dose), plus metformin XR | Experimental |
| |
| Dapagliflozin(high dose), plus metformin XR | Active Comparator |
| |
| Prusogliptin, Dapagliflozin(low dose), plus metformin XR | Experimental |
| |
| Dapagliflozin(low dose), plus metformin XR | Active Comparator |
| |
| Prusogliptin, plus metformin XR | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prusogliptin, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR | Drug | Prusogliptin, Dapagliflozin(high dose) and Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in HbA1c at Week 24 | From baseline to week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with HbA1c of ≤6.5% and HbA1c of ≤7% at week 24 | From baseline to week 24 | |
| Relative change from baseline in HbA1c at week 12 | From baseline to week 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No. 896, Zhongshan East Road, High-tech Industrial Development Zone | Shijiazhuang | Hebei | 050035 | China |
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Multicenter, Randomized, Double-blind, Parallel-controlled
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|
| Prusogliptin placebo, Dapagliflozin(high dose), Dapagliflozin (low dose) placebo, plus metformin XR | Drug | Prusogliptin placebo, Dapagliflozin (high dose), Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose |
|
| Prusogliptin, Dapagliflozin(high dose) placebo, Dapagliflozin (low dose), plus metformin XR | Drug | Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose |
|
| Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), plus metformin XR | Drug | Prusogliptin placebo, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose), once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose |
|
| Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin(low dose) placebo, plus metformin XR | Drug | Prusogliptin, Dapagliflozin (high dose) placebo, Dapagliflozin (low dose) placebo, once a day, 1 tablet per dose; Metformin XR, Once a day, the dosage remains the same as the pre-screening dose |
|
| Relative change from baseline in FPG at week 12 and week 24 |
| From baseline to week 12 and week 24 |
| Relative change from baseline in 2h-PPG at week 12 and week 24 | From baseline to week 12 and week 24 |
| Relative change from baseline in weight at week 12 and week 24 | From baseline to week 12 and week 24 |
| Relative change from baseline in blood pressure at week 12 and week 24 | From baseline to week 12 and week 24 |
| Relative change from baseline in blood lipid level at week 12 and week 24 | From baseline to week 12 and week 24 |
| Relative change from baseline in 7-point blood glucose levels and average post-meal blood glucose increments at week 24 | From baseline to week 24 |
| Proportion of participants who received rescue treatment after 24 weeks of treatment | From baseline to week 24 |
| 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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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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