Rosenstock J, et al. – An analysis was designed to assess the utility and safety of ertugliflozin, an SGLT2 inhibitor, in type 2 diabetes mellitus (T2DM) inadequately controlled (HbA1c, 7.0–10.5%) on metformin monotherapy (≥1500 mg/day for ≥8 weeks). The results of this study showed that ertugliflozin added to metformin in inadequately controlled T2DM improved glycaemic control, reduced body weight and BP, but increased genital mycotic infections.

Methods

• Double–blind, 26–week, multicentre study with ongoing 78–week extension; 621 participants randomized 1:1:1 to placebo, ertugliflozin 5 or 15 mg/day.
• Preliminary outcome: change from baseline in HbA1c at week 26. Secondary efficacy endpoints: change from baseline at week 26 in fasting plasma glucose (FPG), body weight, systolic/diastolic blood pressure (SBP/DBP); participants with HbA1c
• At week 26, they also measured pre–specified adverse events (AEs) of special interest and percent change from baseline in bone mineral density (BMD).

Results

• The placebo–adjusted least–squares mean change from baseline HbA1c (8.1%) was –0.7% and –0.9% for ertugliflozin 5 and 15 mg, respectively (both P
• The odds of HbA1c
• The data illustrated that ertugliflozin significantly reduced FPG, body weight, SBP and DBP vs placebo.
• They observed that incidence of genital mycotic infections was increased in ertugliflozin groups (females: placebo, 0.9%; ertugliflozin 5 mg, 5.5%; 15 mg, 6.3% [P = 0.032]; males: 0; 3.1%; 3.2%), as was incidence of urinary tract infections and symptomatic hypoglycaemia. Incidence of hypovolaemia AEs was similar across groups.
• At week 26, ertugliflozin had no adverse impact on BMD.