Efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus and established cardiovascular disease using insulin - a VERTIS CV sub-study.

AIM To assess the efficacy and safety of ertugliflozin in patients with type 2 diabetes mellitus (T2DM) and established atherosclerotic cardiovascular disease (ASCVD) inadequately controlled by insulin. MATERIALS AND METHODS VERTIS CV was the cardiovascular outcome study for ertugliflozin. Patients were randomly assigned to placebo, ertugliflozin 5- or 15-mg once-daily. We report results of a sub-study in patients on stable dose of insulin ≥20 units/day. The primary endpoint was HbA1c change from baseline to 18 weeks. Secondary endpoints were changes in fasting plasma glucose (FPG), body weight (BW), the proportion of patients with HbA1c <7%, systolic blood pressure (SBP), diastolic blood pressure and insulin dose. RESULTS Of 8246 patients randomized in VERTIS CV, 1065 were included in the sub-study (male: 68.2%; mean [SD] age: 64.8 [7.8] years; T2DM duration: 16.7 [9.0] years; HbA1c: 8.4% [1.0]). At Week 18, least squares (LS) mean change from baseline in HbA1c was significantly greater with ertugliflozin 5- and 15-mg versus placebo (placebo-adjusted LS mean [95% CI] change: -0.58% [-0.71, -0.44] and -0.65% [-0.78, -0.51], respectively; P < .001 for both). Ertugliflozin significantly reduced FPG, BW, and SBP. In women, the incidence of genital mycotic infections was higher with ertugliflozin (3.5%) versus placebo (0.0%). The incidence of symptomatic hypoglycaemia was similar across treatment groups. CONCLUSIONS Ertugliflozin added to insulin improved glycaemic control, BW and SBP versus placebo at 18 weeks in patients with T2DM and ASCVD. ClinicalTrials.gov identifier: NCT01986881. This article is protected by copyright. All rights reserved.