Study to Evaluate The Efficacy and Safety of Ertugliflozin in Subjects With Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Metformin Monotherapy

Mise à jour : Il y a 4 ans
Référence : EUCTR2013-003290-95

Femme et Homme

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Extrait

The primary objectives and hypotheses of the trial are: 1. Objective: At Week 26, to assess the effect on HbA1c of 15 mg ertugliflozin as compared with placebo. Hypothesis: At Week 26, the mean reduction from baseline in HbA1c for 15 mg ertugliflozin is greater than that for placebo. 2. Objective: At Week 26, to assess the effect on HbA1c of 5 mg ertugliflozin as compared with placebo. Hypothesis: At Week 26, the mean reduction from baseline in HbA1c for 5 mg ertugliflozin is greater than that for placebo. 3.Objective: To assess the safety and tolerability of ertugliflozin.


Critère d'inclusion

  • Type 2 diabetes mellitus