PMID- 30830724 OWN - NLM STAT- MEDLINE DCOM- 20200529 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 21 IP - 6 DP - 2019 Jun TI - Safety and efficacy of ertugliflozin in Asian patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy: VERTIS Asia. PG - 1474-1482 LID - 10.1111/dom.13681 [doi] AB - 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. CI - (c) 2019 John Wiley & Sons Ltd. FAU - Ji, Linong AU - Ji L AUID- ORCID: 0000-0003-1305-1598 AD - Peking University People's Hospital, Beijing, China. FAU - Liu, Yanmei AU - Liu Y AD - Yancheng First People's Hospital, Yancheng, China. FAU - Miao, Heng AU - Miao H AD - The Second Affiliated Hospital of Nanjing Medical University, Nanjing, China. FAU - Xie, Yongli AU - Xie Y AD - Pingxiang People's Hospital, Pingxiang, China. FAU - Yang, Ming AU - Yang M AD - Pfizer (China) R&D Co., Shanghai, China. FAU - Wang, Wei AU - Wang W AD - Pfizer (China) R&D Co., Shanghai, China. FAU - Mu, Yuting AU - Mu Y AD - Pfizer (China) R&D Co., Shanghai, China. FAU - Yan, Ping AU - Yan P AD - Pfizer (China) R&D Co., Shanghai, China. FAU - Pan, Sharon AU - Pan S AD - Pfizer Inc., New York, New York. FAU - Lauring, Brett AU - Lauring B AD - Merck & Co., Inc., Kenilworth, New Jersey. FAU - Liu, Shu AU - Liu S AD - MSD China, Beijing, China. FAU - Huyck, Susan AU - Huyck S AD - Merck & Co., Inc., Kenilworth, New Jersey. FAU - Qiu, Yanping AU - Qiu Y AD - MSD China, Beijing, China. FAU - Terra, Steven G AU - Terra SG AUID- ORCID: 0000-0002-5815-6193 AD - Pfizer Inc., Andover, Massachusetts. LA - eng SI - ClinicalTrials.gov/NCT02630706 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20190405 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Bridged Bicyclo Compounds, Heterocyclic) RN - 0 (Sodium-Glucose Transporter 2 Inhibitors) RN - 6C282481IP (ertugliflozin) RN - 9100L32L2N (Metformin) SB - IM MH - Aged MH - Bridged Bicyclo Compounds, Heterocyclic/administration & dosage/*adverse effects/therapeutic use MH - Diabetes Mellitus, Type 2/*drug therapy MH - Drug-Related Side Effects and Adverse Reactions MH - Asia, Eastern MH - Female MH - Humans MH - Male MH - Metformin/adverse effects/therapeutic use MH - Middle Aged MH - Philippines MH - Sodium-Glucose Transporter 2 Inhibitors/administration & dosage/*adverse effects/therapeutic use PMC - PMC7379575 OTO - NOTNLM OT - Asia OT - SGLT2 inhibitor OT - ertugliflozin OT - type 2 diabetes mellitus COIS- L.J., Y.L., H.M. and Y.X. declare no conflicts of interest. Y.M. is an employee of Pfizer (China) R&D Co. S.P. and S.G.T. are employees of Pfizer Inc. S.L. is an employee of MSD China. S.H. is an employee of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA. M.Y., P.Y. and W.W. were employees of Pfizer (China) R&D Co. at the time of study conduct. B.L. and Y.Q. were employees of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, at the time of study conduct. S.G.T. owns stocks in Pfizer Inc. S.P., M.Y., Y.M. and P.Y. own stocks in Pfizer (China) R&D Co., and S.H. owns stocks in Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Kenilworth, NJ, USA. 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. EDAT- 2019/03/05 06:00 MHDA- 2020/05/30 06:00 PMCR- 2020/07/24 CRDT- 2019/03/05 06:00 PHST- 2018/11/26 00:00 [received] PHST- 2019/02/15 00:00 [revised] PHST- 2019/02/28 00:00 [accepted] PHST- 2019/03/05 06:00 [pubmed] PHST- 2020/05/30 06:00 [medline] PHST- 2019/03/05 06:00 [entrez] PHST- 2020/07/24 00:00 [pmc-release] AID - DOM13681 [pii] AID - 10.1111/dom.13681 [doi] PST - ppublish SO - Diabetes Obes Metab. 2019 Jun;21(6):1474-1482. doi: 10.1111/dom.13681. Epub 2019 Apr 5.