Efficacy and safety of ertugliflozin in East/Southeast Asian patients with type 2 diabetes mellitus

Abstract

Aim: Post-hoc analysis of the efficacy and safety of ertugliflozin in East/Southeast (E/SE) Asian patients with type 2 diabetes mellitus (T2DM).

Materials and methods: Efficacy evaluations used data from randomized, double-blind, phase 3 studies: a pool of two 26-week placebo-controlled studies and one 52-week active-comparator (glimepiride) study. Least squares mean change from baseline was calculated for HbA1c, fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events based on pooled data (broad pool) from seven phase 3 studies (including studies in the efficacy analysis).

Results: Among 161 E/SE Asian patients in the placebo pool (ertugliflozin, n = 106), ertugliflozin reduced HbA1c, FPG, BW and SBP from baseline at week 26. The placebo-adjusted changes from baseline for ertugliflozin 5 and 15 mg were: HbA1c, -0.9% and -1.0%; BW, -2.1 and -1.9 kg; and SBP, -3.3 and -3.5 mmHg, respectively. Among 174 E/SE Asian patients in the active-comparator study (ertugliflozin, n = 118), HbA1c changes from baseline at week 52 were -0.6%, -0.6% and -0.7% for ertugliflozin 5 mg, 15 mg and glimepiride, respectively. Ertugliflozin 5 and 15 mg reduced BW from baseline by -4.3 and -4.1 kg, respectively, and SBP by -7.4 and -9.3 mmHg, respectively, compared with glimepiride. Safety findings were generally consistent with overall ertugliflozin safety data published to date.

Conclusions: Treatment with ertugliflozin was associated with reductions in HbA1c, FPG, BW and SBP, and was generally well tolerated in E/SE Asian patients with T2DM. ClinicalTrials.gov identifier: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, NCT02226003.

Keywords: sodium-glucose cotransporter 2 inhibitor; type 2 diabetes mellitus.

Conflict of interest statement

J. L., S. P., L. W., S. H., A. P. and I. G. are employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, and own stock in Merck & Co., Inc., Kenilworth, NJ, USA. N. B. C., S. G. T., A. H. and A. D. are employees of Pfizer Inc. and own stock in Pfizer Inc, New York, NY, USA.

© 2019 Pfizer Inc. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Figures

Figure 1

Phase 3 VERTIS studies included in the East and Southeast (E/SE) Asia post‐hoc analysis.9, 10, 11, 12, 13, 14, 15 AHA, antihyperglycaemic agent; E5, ertugliflozin 5 mg; E15, ertugliflozin 15 mg; NCT, http://clinicaltrials.gov identifier; S100, sitagliptin 100 mg. aNot included in efficacy analysis as no patients (MONO and SITA) or <20 patients per treatment arm (FACTORIAL and RENAL) were enrolled from E/SE Asian countries

Figure 2

(A) Least squares (LS) mean change from baseline in HbA1c; (B) proportion of patients with HbA1c aLS mean (95% CI) difference vs. placebo or glimepiride

Figure 3

Least squares (LS) mean change from baseline in (A) body weight and (B) systolic blood pressure (SBP) at week 26 and week 52 for East and Southeast (E/SE) Asian and non‐E/SE Asian patients (full analysis set [FAS] population, excluding rescue approach). CI, confidence interval; ERTU, ertugliflozin; GLIM, glimepiride; PBO, placebo. aLS mean (95% CI) difference vs. placebo or glimepiride