Cardiovascular (CV) Safety and Severe Hypoglycemia Benefit of Insulin Degludec vs. Insulin Glargine U100 in Older Patients (=65 Years) with Type 2 Diabetes (T2D)—Observations from DEVOTE
Authors: PRATLEY RICHARD E. , EMERSON SCOTT S. , FRANEK EDWARD , GILBERT MATTHEW P. , MARSO STEVEN P. , MCGUIRE DARREN K. , PIEBER THOMAS R. , POULTER NEIL R. , HANSEN CHARLOTTE T. , HANSEN MELISSA V. , MARK THOMAS , MOSES ALAN C. , ZINMAN BERNARD ,   ON BEHALF OF THE DEVOTE STUDY GROUP
Published: June 2018

There is limited comparative evidence for the CV safety and hypoglycemia risk of basal insulins in older patients with T2D. This secondary analysis from DEVOTE investigated the CV safety and severe hypoglycemia risk of insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100) in older patients (65-74 and ?75 years age groups). Data from DEVOTE (a treat-to-target, randomized, double-blind trial evaluating 7637 patients with T2D over a median period of 2 years at high risk of CV events) were stratified by three age groups. At baseline, A1C, fasting plasma glucose and estimated glomerular filtration rates decreased with increasing age. Older patients had a higher risk of major adverse cardiovascular events (MACE), all-cause mortality and severe hypoglycemia, regardless of treatment. Treatment differences for MACE, all-cause mortality and severe hypoglycemia were similar across age groups (Figure), with no significant interactions between treatment and age group. Degludec was associated with a lower risk of severe hypoglycemia vs. glargine U100, regardless of age. This analysis supported the CV safety of degludec and demonstrated a lower risk of severe hypoglycemia vs. glargine U100 in older patients with T2D.

Disclosure
R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc. S.S. Emerson: Consultant; Self; Bayer AG, CTI BioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals Group, Genentech, Inc., GlaxoSmithKline plc., Janssen Research & Development, Novartis AG, Novo Nordisk A/S, Pfizer Inc., Roche Pharma, Allergan, AstraZeneca, Coherus Biosciences Inc, Emmaus Life Sciences Inc., Indivior, Sandoz, Seattle Genetics. Research Support; Self; National Heart, Lung, and Blood Institute. E. Franek: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim GmbH, Merck Sharp & Dohme Corp., Novo Nordisk A/S. Speaker's Bureau; Self; AstraZeneca, Bristol-Myers Squibb Company, Boehringer Ingelheim GmbH, Eli Lilly and Company, Merck & Co., Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Servier. M.P. Gilbert: Consultant; Self; Sanofi US, Novo Nordisk A/S. S.P. Marso: Consultant; Self; Abbott Vascular, Novo Nordisk A/S, University of Oxford, AstraZeneca, Bristol-Myers Squibb Company. Research Support; Self; Novo Nordisk A/S, The Medicines Company, Terumo Medical Corporation. D.K. McGuire: Consultant; Self; AstraZeneca, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Lexicon Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Esperion Therapeutics. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. N.R. Poulter: Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc.. Research Support; Self; Servier. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc., Servier. Other Relationship; Self; International Society of Hypertension. 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. T. Mark: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. A.C. Moses: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. B. Zinman: Consultant; Self; Novo Nordisk A/S, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi, Merck & Co., Inc., Abbott.