Vulnerability to hypoglycemia increases with age. To further assess the safety of insulin in older patients, the risk of hypoglycemia was investigated post-hoc in the SWITCH 2 treat-to-target, 64-week, crossover trial. Patients with T2D and high risk of hypoglycemia were randomized, double-blind, to either degludec or insulin glargine U100 ± OADs. The primary endpoint was the number of positively adjudicated severe (external assistance) or symptomatic hypoglycemic events (plasma glucose <56 mg/dL) during the two 16-week maintenance periods. For patients ?65 (n=450) and >65 (n=270) years, baseline median [range] diabetes duration was 12.0 [1-40] vs. 15 [1-54] years, mean A1C was 7.7 vs. 7.4%, and mean eGFR was 87.0 vs. 63.7 mL/min/1.73m2. No significant differences in A1C reduction (degludec vs. glargine U100) were seen for patients ?65 and >65 years. During the maintenance period, degludec had a lower risk of hypoglycemia (overall/nocturnal symptomatic) vs. glargine U100 in patients ?65 (31/43%) and >65 years (30/41%) (Figure). The number of severe hypoglycemia episodes was not significantly lower. The adverse event rate was 3.2 and 3.3 events/patient-year for ?65 years and 3.5 and 4.1 events/patient-year for >65 years, for degludec and glargine U100, respectively. Degludec was safe and effective, and the frequency of hypoglycemia was lower than glargine U100 in patients ?65 and >65 years with T2D.
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S.R. Heller: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk A/S, Takeda, Sanofi-Aventis, Boehringer Ingelheim GmbH. Consultant; Self; Eli Lilly and Company, Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Merck Sharp & Dohme Corp., Takeda, AstraZeneca, Boehringer Ingelheim GmbH. J. DeVries: Research Support; Self; Dexcom, Inc., Medtronic, Novo Nordisk A/S. Advisory Panel; Self; Novo Nordisk A/S. Speaker's Bureau; Self; Novo Nordisk A/S, Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Sanofi. Research Support; Self; Senseonics. Speaker's Bureau; Self; Senseonics. Advisory Panel; Self; Zealand Pharma A/S. C.H. Wysham: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi. Consultant; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Insulet Corporation, Novo Nordisk Inc., Sanofi. C.T. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. M.V. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. B.M. Frier: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company. Consultant; Self; Locemia Solutions, Zucara Therapeutics. Speaker's Bureau; Self; Novo Nordisk A/S, Eli Lilly and Company, Roche Pharma, AstraZeneca.

© 2018 by the American Diabetes Association.
2018
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