1097-P: Glycemic Control and Safety Profile of Insulin Glargine 300 U/mL in Older Adults—REALI Pooled Data Analysis

Abstract

Despite an increasing number of patients with type 2 diabetes (T2D) in the older population, clinical evidence for different therapeutic strategies in the elderly is poor. Therefore, we used the REALI pooled database, which includes a large number of studies conducted in different European countries to evaluate the impact of initiating insulin glargine 300 U/mL (Gla-300) in older patients with T2D. Pooled efficacy and safety analyses of data from three interventional and five observational studies (pooled treated patients, n=5806) were performed on three age groups of patients: <65 (n=2874), 65 to <75 (n=1819), and ≥75 years old (y.o.) (n=1105); age data were missing for 8 patients. The proportion of females, median diabetes duration at baseline and prior use of insulin glargine 100 U/mL increased with age, whereas mean body weight and mean eGFR at baseline decreased with age. Diabetes complications and/or concomitant cardiovascular diseases and risk factors were more frequent in patients ≥75 y.o. Mean (SD) HbA1c (%) at baseline was 8.61 (1.08), 8.42 (0.95), and 8.39 (0.94) in the <65, 65 to <75, and ≥75 y.o. age groups, respectively. The least square mean [95% confidence interval] HbA1c change from baseline to Week 24 of Gla-300 treatment was -0.87 [-0.93; -0.82], -0.83 [-0.89; -0.77] and -0.77 [-0.88; -0.67], respectively. Similar proportions of patients reached the HbA1c <7% and <7.5% goals at Week 24 across the three age groups, with no notable differences between the age groups in incidence of severe (0.7%, 1.2% and 1.2% respectively) and nocturnal (3.1%, 3.6% and 1.7% respectively) hypoglycemia, or mean change in body weight and Gla-300 dose (U/Kg/day) from baseline to Week 24. Gla-300 was well tolerated across all age groups. This pooled data analysis shows that initiation of treatment with insulin glargine 300 U/mL in older (≥ 75 y.o) patients with T2D has a similar efficacy and safety profile as in younger adults, and extends the evidence on treatment of older patients. Disclosure R.C. Bonadonna: Advisory Panel; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Sanofi-Aventis. Speaker's Bureau; Self; Eli Lilly and Company, Sanofi-Aventis. D. Mauricio: Advisory Panel; Self; Merck Sharp & Dohme Corp., Sanofi. Speaker's Bureau; Self; Almirall, S.A., Boehringer Ingelheim International GmbH, Lilly Diabetes, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi, Urgo Medical. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. N. Freemantle: Advisory Panel; Self; Sanofi. Research Support; Self; Akcea Therapeutics, Allergan, AstraZeneca, Ipsen Biopharmaceuticals, Inc., Sanofi, Takeda Pharmaceutical Company Limited. Speaker's Bureau; Self; Sanofi. G. Bigot: None. C. Mauquoi: None. A. Ciocca: Employee; Self; Sanofi. M. Bonnemaire: Employee; Self; Sanofi. P. Gourdy: Advisory Panel; Self; AstraZeneca. Board Member; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. Speaker's Bureau; Self; Abbott, Amgen Inc., Eli Lilly and Company, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis, Servier. Funding Sanofi