Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2 weeks screening period, 4 weeks run-in period, 24 weeks double-blind treatment period, to evaluate the Safety and Efficacy of Retagliptin Plus Henagliflozein added to Metformin compared to Retagliptin or Henagliflozein in combination with Metformin in Subjects with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retagliptin 100 mg, Henagliflozein 10 mg, plus metformin XR | Experimental |
| |
| Retagliptin 100 mg, Henagliflozein 5 mg, plus metformin XR | Experimental |
| |
| Retagliptin placebo, Henagliflozein 10 mg, plus metformin XR | Experimental |
| |
| Retagliptin placebo, Henagliflozein 5 mg, plus metformin XR | Experimental |
| |
| Retagliptin 100 mg, Henagliflozein placebo, plus metformin XR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retagliptin, Henagliflozein, metformin XR | Drug | Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in HbA1c at Week 24 | • To compare the mean change from baseline in HbA1c achieved with concurrent addition of Retagliptin Plus Henagliflozein to metformin vs the addition of Retagliptin or Henagliflozein to metformin after 24 weeks of double-blind treatment. | 24 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |