A clinical trial to test if the drug ertugliflozin is safe and effective when compared to placebo in patients with Type 2 Diabetes whose sugar levels are not well controlled by their current treatment...

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-003697-26

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

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Extrait

After 26 weeks, in subjects with T2DM and inadequate glycemic control on treatment with metformin ≥1500 mg/day and sitagliptin 100 mg q.d.: 1) To assess the A1C-lowering efficacy of the addition of ertugliflozin 15 mg q.d. relative to the addition of placebo. 2) To assess the A1C-lowering efficacy of the addition of ertugliflozin 5 mg q.d. relative to the addition of placebo. 3) To assess the safety and tolerability of the addition of ertugliflozin.


Critère d'inclusion

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