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Randomized Controlled Trial
. 2019 Jun;21(6):1474-1482.
doi: 10.1111/dom.13681. Epub 2019 Apr 5.

Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia

Linong Ji  1 , Yanmei Liu  2 , Heng Miao  3 , Yongli Xie  4 , Ming Yang  5 , Wei Wang  5 , Yuting Mu  5 , Ping Yan  5 , Sharon Pan  6 , Brett Lauring  7 , Shu Liu  8 , Susan Huyck  7 , Yanping Qiu  8 , Steven G Terra  9
Affiliations
Randomized Controlled Trial

Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia

Linong Ji et al. Diabetes Obes Metab. 2019 Jun.

Abstract

Aim: Phase III, randomized, double-blind study evaluating the efficacy and safety of ertugliflozin in Asian patients with type 2 diabetes mellitus (T2DM) inadequately controlled on metformin, including evaluation in the China subpopulation.

Materials and methods: A 26-week, double-blind study of 506 Asian patients (80.2% from mainland China), randomized 1:1:1 to placebo, ertugliflozin 5- or 15 mg, was performed. Primary endpoint was change from baseline in HbA1c at week 26. Secondary endpoints were change from baseline at week 26 in fasting plasma glucose (FPG), body weight (BW), systolic/diastolic blood pressure (SBP/DBP), and proportion of patients with HbA1c <7.0%. Hypotheses for the primary endpoint and FPG and BW secondary endpoints were tested in the China subpopulation.

Results: At week 26, least squares mean (95% CI) change from baseline HbA1c was significantly greater with ertugliflozin 5- and 15 mg versus placebo: -1.0% (-1.1, -0.9), -0.9% (-1.0, -0.8), -0.2% (-0.3, -0.1), respectively. Ertugliflozin significantly reduced FPG, BW and SBP. Reductions in DBP with ertugliflozin were not significant. At week 26, 16.2%, 38.2% and 40.8% of patients had HbA1c <7.0% with placebo, ertugliflozin 5- and 15 mg, respectively. 59.3%, 56.5% and 53.3% of patients experienced adverse events with placebo, ertugliflozin 5- and 15 mg, respectively. Incidence of symptomatic hypoglycaemia was higher for ertugliflozin 15 mg vs placebo. Results in the China subpopulation were consistent.

Conclusions: Ertugliflozin significantly improved glycaemic control and reduced BW and SBP in Asian patients with T2DM. Ertugliflozin was generally well-tolerated. Results in the China subpopulation were consistent with the overall population. ClinicalTrials.gov: NCT02630706.

Keywords: Asia; SGLT2 inhibitor; ertugliflozin; type 2 diabetes mellitus.

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Conflict of interest statement

Author contributions

All authors critically reviewed the draft manuscript and approved the final version of the manuscript for publication. M.Y., W.W., Y.M., S.P., P.Y. and S.G.T. were involved in the conception/design of the study. L.J., Y.L., H.M. and Y.X. were involved in the acquisition of data for the study. All authors were involved in data analysis and interpretation of the data.

Figures

Figure 1
Figure 1
Least squares mean change from baseline in HbA1c over time for overall population. Based on cLDA model with fixed effects for treatment, time, antihyperglycaemic medication status at screening, baseline eGFR (continuous) and the interaction of time by treatment. Time was treated as a categorical variable. cLDA, constrained longitudinal data analysis; eGFR, estimated glomerular filtration rate; LS, least squares; SE, standard error
Figure 2
Figure 2
Efficacy outcomes in overall population: A, least squares mean change from baseline in HbA1c at week 26; B, proportion of patients with HbA1c <7% at week 26; C, LS mean change from baseline in FPG at week 26; D, LS mean change from baseline in body weight at week 26; E, LS mean change from baseline in systolic BP at week 26; F, LS mean change from baseline in diastolic BP at week 26; BP, blood pressure; CI, confidence interval; FPG, fasting plasma glucose; LS, least squares
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