Efficacy and Safety of Ertugliflozin Added to Metformin: A Pooled Population from Asia with Type2 Diabetes and Overweight or Obesity.

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The efficacy and safety of ertugliflozin have not been well characterized in Asian populations with type2 diabetes (T2D) and overweight or obesity as defined by the Chinese Diabetes Society [body mass index (BMI)≥24kg/m2]. These post hoc analyses of pooled data from two randomized, double-blind, 26-week studies assessed the efficacy and safety of ertugliflozin (5mg or 15mg) compared with placebo in participants from Asia with T2D and baseline BMI ≥ 24kg/m2, with inadequate glycemic control on metformin. Longitudinal analyses were used to calculate least squares (LS) mean [95% confidence interval (CI)] change from baseline in glycemic indices and body weight. The proportions of participants achieving efficacy targets and experiencing adverse events (AEs) were assessed. The 445 participants had a mean age of 55.5years, T2D duration 6.6years, glycated hemoglobin (HbA1c) 8.1%, and BMI 27.6kg/m2. At week26, placebo-adjusted LS mean (95%CI) changes from baseline for ertugliflozin 5mg and 15mg, respectively, were -0.78% (-0.95% to -0.61%) and -0.80% (-0.98% to -0.63%) for HbA1c, and -1.74kg (-2.29kg to -1.19kg) and -2.04kg (-2.60kg to -1.48kg) for body weight. A greater proportion of participants receiving ertugliflozin 5mg and 15mg versus placebo, respectively, achieved HbA1c < 7.0% (42.1% and 46.3% vs. 13.9%), body weight reduction≥5% (35.5% and 38.3% vs. 11.1%), and systolic blood pressure<130mmHg (42.4% and 34.5% vs. 21.7%). The proportion of participants with AEs was 52.6% (ertugliflozin 5mg), 52.3% (ertugliflozin 15mg), and 55.6% (placebo). In participants from Asia with T2D inadequately controlled by metformin monotherapy, and BMI≥24kg/m2, ertugliflozin (5mg or 15mg) resulted in greater glycemic and body weight reductions compared with placebo and was generally well tolerated. Clinicaltrials.gov identifiers NCT02033889, NCT02630706.