375-P: Switching to Insulin Degludec from Other Basal Insulins Reduces Rates of Hypoglycemia across Patient Subgroups in Routine Clinical Care: The ReFLeCT Study

Abstract

ReFLeCT, a multicenter, prospective, observational study evaluated the safety and effectiveness of switching from other basal insulins to insulin degludec (degludec) in patients with type 1 (T1D) or type 2 diabetes (T2D) in routine clinical practice. ReFLeCT comprised a 4-week baseline period (pre-switch basal insulin) and 12-month follow-up period (degludec). The primary endpoint of overall hypoglycemia reported in patient diaries was reduced during the 12-month follow-up period vs. baseline, without compromising glycemic control. In pre-specified subgroup analyses of the primary endpoint, we assessed if the overall result was robust in different subgroups, characterized according to baseline A1C (<7.5, ≥7.5-<8.5, ≥8.5-<9.5, ≥9.5%), diabetes duration (quartiles) and physician’s reason for initiating degludec (hypoglycemia [Yes/No]). The estimated rate ratios of hypoglycemia were similar within subgroups (no significant interactions), and demonstrated overall lower rates (the majority significantly lower) during the 12-month follow-up periods vs. baseline in patients with T1D or T2D (Figure). Irrespective of baseline characteristics or physician’s reason for initiating degludec, switching to degludec from other basal insulins reduced rates of overall hypoglycemia in patients with T1D or T2D, in routine clinical practice. Disclosure H.W. de Valk: Advisory Panel; Self; Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S. M. Feher: Advisory Panel; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Research Support; Self; Amgen Inc., Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. T.K. Hansen: None. J.H. Jendle: Advisory Panel; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Board Member; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Abbott, Dexcom, Inc., Medtronic, Novo Nordisk A/S. Speaker's Bureau; Self; Eli Lilly and Company, Medtronic, Nordic Infucare, Novo Nordisk A/S, Sanofi. Á. Merchante: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Research & Development, Mundipharma International, Novo Nordisk A/S, Nutricia, Persan Pharma. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. M.M. Koefoed: Employee; Self; Novo Nordisk A/S. E. Parvaresh Rizi: Employee; Self; Nestlé, Novo Nordisk A/S. E. Zimmermann: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. G. Fadini: Consultant; Self; AstraZeneca, Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Novo Nordisk A/S, Sanofi. Speaker's Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi. Funding Novo Nordisk A/S