Similar or Lower Severe Hypoglycemia Rates with Insulin Glargine 300 U/mL (Gla-300) vs. Glargine 100 U/mL (Gla-100), Detemir (IDet), and Insulin Degludec (IDeg) in 112,626 People with Type 2 Diabetes Mellitus (T2DM)—Predictive Modeling Using Real-World Data—Lightning

Abstract

Real-world U.S. electronic health record (EHR) data, representative of the general population and real-life practice, were used to predict hypoglycemia rates in people with T2DM prescribed basal insulin (BI) analogs. Hypoglycemic events during BI treatment, as recorded by physicians in EHR, including patients initiating BI (“insulin-naïve”) and switching between BIs (“switchers”), were collected between 01 April 2015 and 31 March 2017. Based on real-world data, a predictive model (implementing machine learning and controlling for >160 baseline demographic and clinical variables) was developed and validated for each drug-specific cohort (patients treated with specific BI). The models predict significantly lower rates of severe hypoglycemia in real-world use with Gla-300 vs. Gla-100 or IDet, irrespective of prior insulin use. In insulin-naïve patients, lower rates of severe hypoglycemia are predicted with Gla-300 vs. IDeg (p<0.05), an unexpected finding that warrants further investigation, whereas comparable rates are shown in switchers (Figure). In summary, using real-world data, these predictive modeling results show similar or significantly lower severe hypoglycemia rates with Gla-300 vs. other BI in people with T2DM. Disclosure J. Pettus: Advisory Panel; Self; Sanofi, Novo Nordisk Inc.. Consultant; Self; MannKind Corporation. Advisory Panel; Self; Insulet Corporation. Consultant; Self; Senseonics. T.S. Bailey: Research Support; Self; Abbott. Consultant; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Ambra BioScience, Ascensia Diabetes Care, Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Calibra Medical. Consultant; Self; Calibra Medical. Research Support; Self; Companion Medical, Dexcom, Inc., Glooko, Inc., GlySens Incorporated, Lexicon Pharmaceuticals, Inc., Eli Lilly and Company. Consultant; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Research Support; Self; Medtronic MiniMed, Inc.. Consultant; Self; Medtronic MiniMed, Inc.. Speaker's Bureau; Self; Medtronic MiniMed, Inc.. Research Support; Self; Novo Nordisk Inc.. Consultant; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Research Support; Self; Sanofi. Consultant; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; Senseonics. Consultant; Self; Intarcia Therapeutics, Inc.. Research Support; Self; Versartis, Inc., Xeris Pharmaceuticals, Inc., MannKind Corporation. F.L. Zhou: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. Employee; Spouse/Partner; Lexicon Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Lexicon Pharmaceuticals, Inc. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Westerbacka: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. R. Berria: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. J. Jimenez: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. I. Hramiak: Advisory Panel; Self; AstraZeneca. Research Support; Self; AstraZeneca. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Eli Lilly and Company. Advisory Panel; Self; GlaxoSmithKline plc.. Research Support; Self; GlaxoSmithKline plc.. Advisory Panel; Self; Roche Pharma, Insulet Corporation, Janssen Pharmaceuticals, Inc.. Research Support; Self; Janssen Pharmaceuticals, Inc.. Speaker's Bureau; Self; Janssen Pharmaceuticals, Inc.. Research Support; Self; Lexicon Pharmaceuticals, Inc., Medtronic. Advisory Panel; Self; Merck & Co., Inc.. Research Support; Self; Merck & Co., Inc.. Speaker's Bureau; Self; Merck & Co., Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Sanofi. Research Support; Self; Sanofi. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association.