Efficacy and Safety of Continuing Sitagliptin when Initiating Insulin Therapy in Subjects with Type 2 Diabetes Mellitus

DPP-4 inhibitors (DPP-4is) are often discontinued with initiation of insulin therapy but the impact of this discontinuation on efficacy and hypoglycemia has not been studied. In this double-blind trial the safety and efficacy of initiating insulin while continuing sitagliptin (SITA) was evaluated. Eligible patients had inadequately controlled T2DM on metformin (MET, ≥ 1500 mg/day) in dual or triple combination therapy with a DPP-4i and/or sulfonylurea. Those on MET + SITA (100 mg/day) directly entered the trial; all others were switched to MET + SITA and stabilized during a run-in period. Subjects were randomized to continuing SITA or discontinuing SITA and switching to matching placebo, with both groups initiating insulin (LANTUS®), which was titrated based on fasting glucose. 746 subjects (mean A1C 8.8%, disease duration 10.6 years) were randomized. After 30 weeks, continuing SITA was superior to discontinuing SITA in reducing A1C (p In summary, with the initiation of insulin therapy, continuation of SITA resulted in superior glycemic efficacy and less documented symptomatic hypoglycemia. Disclosure R. Roussel: Advisory Panel; Self; AbbVie Inc., Abbott, Eli Lilly and Company, Sanofi, Novo Nordisk A/S, AstraZeneca. Speaker9s Bureau; Self; Servier. Consultant; Self; Bayer AG. Advisory Panel; Self; Merck Sharp & Dohme Corp.. Research Support; Self; Amgen Inc., Sanofi, Novo Nordisk A/S, Danone Research. Stock/Shareholder; Self; Iriade. Advisory Panel; Self; Physiogenex S.A.S.. S. Duran-Garcia: None. Y. Zhang: None. S. Shah: Employee; Self; Merck & Co., Inc. C. Darmiento: Employee; Self; Merck & Co., Inc. R. Shankar: Employee; Self; Merck & Co., Inc.. Employee; Spouse/Partner; NGM Biopharmaceuticals. E.A. O9Neill: Employee; Self; Merck & Co., Inc. G.T. Golm: Employee; Self; Merck & Co., Inc. R.L. Lam: Employee; Self; Merck & Co., Inc. I. Gantz: Employee; Self; Merck Sharp & Dohme Corp. K.D. Kaufman: Employee; Self; Merck & Co., Inc. S.S. Engel: Employee; Self; Merck & Co., Inc.. Stock/Shareholder; Self; Merck & Co., Inc..