A clinical trial to test if the combination of ertugliflozin with Sitagliptin is safe and effective when compared to ertugliflozin alone and Sitagliptin alone in patients with Type 2 Diabetes whose su...

Update Il y a 4 ans
Reference: EUCTR2013-003698-82

A clinical trial to test if the combination of ertugliflozin with Sitagliptin is safe and effective when compared to ertugliflozin alone and Sitagliptin alone in patients with Type 2 Diabetes whose sugar levels are not well controlled by their current treatment with Metaformin

Woman and Man

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Extract

In subjects with T2DM and inadequate glycemic control on metformin ≥1500 mg/day, after 26 weeks: 1. To assess the A1C-lowering efficacy of the addition of ertugliflozin 15 mg q.d. plus sitagliptin 100 mg q.d. compared with the addition of sitagliptin 100 mg q.d. alone. 2. To assess the A1C-lowering efficacy of the addition of ertugliflozin 15 mg q.d. plus sitagliptin 100 mg q.d. compared with the addition of ertugliflozin 15 mg q.d. alone. 3. To assess the A1C-lowering efficacy of the addition of ertugliflozin 5 mg q.d. plus sitagliptin 100 mg q.d. compared with the addition of sitagliptin 100 mg q.d. alone. 4. To assess the A1C-lowering efficacy of the addition of ertugliflozin 5 mg q.d. plus sitagliptin 100 mg q.d. compared with the addition of ertugliflozin 5 mg q.d. alone. 5. To assess the safety and tolerability of the addition of ertugliflozin plus sitagliptin 100 mg q.d., ertugliflozin alone, and sitagliptin 100 mg q.d. alone.


Inclusion criteria

  • Treatment of type 2 diabetes mellitus (T2DM) and inadequate glycemic control on treatment with metformin