1109-P: Type 2 Diabetes Treatment in Patients with Chronic Kidney Disease: Efficacy and Safety of Initiating Insulin Glargine 300 U/mL—REALI Pooled Data Analysis

Abstract

Chronic kidney disease is common in patients with type 2 diabetes (T2D) and has an impact on the choice and dosage of T2D therapies, as well as on the individual’s glycemic target and the risk of hypoglycemia. We evaluated the impact of initiating insulin glargine 300 U/mL (Gla-300) in patients with T2D according to eGFR level, using the REALI pooled database which includes several Gla-300 studies conducted in different European countries. Pooled efficacy and safety analysis of data from three interventional studies was performed on patients treated with Gla-300 having an eGFR at baseline either ≥60 (n=923) or <60 mL/min/1.73m² (n=146). Patients in <60 mL/min/1.73m² group were older (mean age 69.6 vs. 62.9 years), had a longer duration of diabetes (median 14.0 vs. 11.0 years), were more frequently pretreated with basal insulin (54.2% vs. 47.3%), and by insulin glargine 100 U/mL (59.0% vs. 54.8%), than in the ≥60 mL/min/1.73m² group. Higher numbers of previous ischemic events and diabetic complications were also identified in patients with an eGFR at baseline <60 mL/min/1.73m². Mean (SD) HbA1c (%) at baseline was 8.44 (0.82) in the <60 mL/min/1.73m² group and 8.55 (0.87) in the ≥60 mL/min/1.73m² group. The least square mean [95% confidence interval] change from baseline to Week 24 of Gla-300 treatment was -0.79 [-0.96; -0.63] and -1.01 [-1.08; -0.95], respectively. The proportion of patients reaching target HbA1c <7% at Week 24 was 23.4% vs. 30.2%, respectively. There were no differences during on-treatment period between the two groups in symptomatic, severe or nocturnal hypoglycemia rates, as well as in the changes in Gla-300 dose (U/kg/day) and in body weight from baseline to Week 24. This pooled data analysis identifies that patients with T2D and reduced kidney function achieve a clinically important improvement in glycemic control, with no safety concerns, at initiation of treatment with insulin glargine 300 U/mL. Disclosure 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. 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. 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. 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. 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. Funding Sanofi