Long-term efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: 104-week VERTIS MET trial
Diabetes, Obesity and Metabolism Feb 20, 2019
Gallo S, et al. - In adults with type 2 diabetes mellitus inadequately controlled on metformin, researchers assessed the long-term effectiveness and safety of ertugliflozin via performing a randomized, double-blind, phase 3 trial. The study duration was 104 weeks with a 26-week placebo-controlled period (Phase A) and a 78-week period (Phase B), in which blinded glimepiride was added to non-rescued placebo participants with fasting fingerstick glucose ≥ 6.1 mmol/L. In week 104, ertugliflozin maintained baseline improvements in HbA1c, fasting plasma glucose (FPG), body weight, and systolic blood pressure (SBP). Overall, ertugliflozin was well tolerated, with changes in bone mineral density that were not clinically relevant. Ertugliflozin increased female genital mycotic infections (GMIs) vs placebo/glimepiride but decreased the incidence of symptomatic hypoglycemia.
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