ReFLeCT was a multicenter, prospective, observational study designed to investigate the safety and effectiveness of switching to degludec from other basal insulins in patients with type 1 (T1D) or type 2 diabetes (T2D). 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 follow-up vs. baseline in T1D and T2D without compromising glycemic control. As different hypoglycemia definitions can impact study outcomes, the previous (pre-specified) and updated (post hoc) American Diabetes Association (ADA) hypoglycemia definitions were analyzed and presented here (Figure). Definitions consisted of, documented asymptomatic and symptomatic, pseudo, probable symptomatic, and Level 1, 2 and 3 (severe) (Figure). Hypoglycemic events were analyzed using fully adjusted, negative binomial regression models. In T1D (n=556) and T2D (n=611), the estimated rate ratios across the previous and the updated ADA hypoglycemia definitions were significantly lower during the 12-month follow-up vs. baseline, except for asymptomatic hypoglycemia in T1D (Figure). Overall, switching to degludec from other basal insulins is associated with lower rates of hypoglycemia across a range of definitions.

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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

© 2019 by the American Diabetes Association.
2019
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