Efficacy and Safety of Ertugliflozin Monotherapy in the Treament of Subjects with Type 2 Diabetes Mellitus and Inadequate Glycemic Control Despite Diet and Exercise

Update Il y a 4 ans
Reference: EUCTR2013-002519-90

Woman and Man

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Extract

(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.


Inclusion criteria

  • Type 2 diabetes mellitus