Visual Abstract
VERTIS CV was a cardiovascular (CV) outcome trial that evaluated the CV safety of ERTU in patients with T2D. In VERTIS CV, 8238 patients received ERTU 5 or 15 mg, or placebo (PBO); doses of background antihyperglycemic medications were to be held constant to Week 18. This analysis assessed the insulin requirements of VERTIS CV patients during the entire study. In 4341 (53%) insulin-naïve patients, insulin was initiated in 12.8% (ERTU 5 mg), 11.6% (ERTU 15 mg) and 17.5% (PBO) of patients after the randomization visit. There was a significantly reduced likelihood of insulin initiation with ERTU 5 and 15 mg vs. PBO (ERTU 5 mg: HR 0.70, 95% CI 0.58-0.84; ERTU 15 mg: HR 0.64, 95% CI 0.53-0.78) and a delay in initiating insulin with ERTU 5 and 15 mg vs. PBO was observed (Figure). In 3897 (47%) patients on insulin at baseline (BL), mean (95% CI) change in insulin dose from BL to Month 60 was −2.47 (−9.65, 4.72) IU/d with ERTU 5 mg, −1.77 (−11.95, 8.42) IU/d with ERTU 15 mg and 9.42 (1.46, 17.39) IU/d with PBO. More patients in the ERTU 15 mg arm (4.1%) had discontinued insulin therapy at end of study than in the ERTU 5 mg (2.4%) or PBO (2.2%) arms. In insulin-naïve patients with T2D, ERTU significantly reduced the likelihood of insulin initiation and delayed new insulin initiations by up to ~1.8 years vs. PBO. In patients already on insulin at BL, ERTU prevented an increase in mean insulin dose.
S. Dagogo-jack: Consultant; Self; Abbott, AstraZeneca, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi US, Stock/Shareholder; Self; Aerami Therapeutics, Jana Care Inc. W. J. Shih: None. U. Masiukiewicz: Employee; Self; Pfizer Inc. I. Gantz: Employee; Self; Merck & Co., Inc. R. E. Pratley: Other Relationship; Self; Hanmi Pharmaceutical, Merck Sharp & Dohme Corp., Metavention, Monster Energy Company, Inc., Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. R. Frederich: Employee; Self; Pfizer Inc., Other Relationship; Self; Merck Sharp & Dohme Corp., Stock/Shareholder; Self; Bristol-Myers Squibb Company, Pfizer Inc. B. Charbonnel: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck & Co., Inc., Mundipharma International, Novo Nordisk, Sanofi, Speaker’s Bureau; Self; Takeda Pharmaceutical Company Limited. J. Liu: Employee; Self; Merck Sharp & Dohme Corp. C. P. Cannon: Advisory Panel; Self; Aegerion Pharmaceuticals Inc., Amarin Corporation plc, Corvidia Therapeutics, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Sanofi, Consultant; Self; Alnylam Pharmaceuticals, Inc., Amgen Inc., Applied Therapeutics, Ascendis Pharma A/S, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, HLS Therapeutics Inc., Kowa Company, Ltd., Research Support; Self; Amgen Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb Company, Daiichi Sankyo, Janssen Research & Development, LLC, Kowa Company, Ltd., Merck & Co., Inc., Novo Nordisk Pharma Ltd., Pfizer Inc. H. Shi: Employee; Self; Pfizer Inc., Employee; Spouse/Partner; Bristol-Myers Squibb Company. D. K. Mcguire: Consultant; Self; Applied Therapeutics, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., CSL Behring, Eli Lilly and Company, Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk, Pfizer Inc., Sanofi. D. Cherney: Other Relationship; Self; AbbVie Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Janssen Scientific Affairs, LLC., Lilly Diabetes, Merck & Co., Inc., Mitsubishi-Tanabe, Maze Inc, Prometic, Novo Nordisk, Sanofi. F. Cosentino: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Pfizer Inc., Speaker’s Bureau; Self; Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Mundipharma International, Novo Nordisk.
