364-P: Efficacy of IGlarLixi on Five-Year Risk of Diabetes-Related Complications: A Simulation Experiment

Abstract

This study assessed the 5-year risk of diabetes complications of iGlarLixi, a fixed-ratio combination of insulin glargine 100 U/ml and lixisenatide, in type 2 diabetes (T2Ds) using a simulation model. The six-month efficacy data of iGlarLixi and Standard of Care (SOC) were extracted from the LixiLan-O trial and ORIGIN trial, and patients’ baseline characteristics were standardized to the ACCORD trial. The BRAVO diabetes simulation model was used to project the 5-year complications based on patients’ baseline characteristics and treatment efficacy. An optimistic scenario where the six-month relative efficacy of iGlarLixi (i.e., iGlarlixi-SOC) lasted for 5 years, and a conservative scenario where the relative effect of iGlarLixi waned to none within 5 years were simulated. iGlarLixi was found to reduce HbA1c (-1.4%), SBP (-3.4 mmHg), and BMI (-0.6 kg/m2) in six-month, compared with SOC. We found a 5-year risk reduction in major adverse cardiovascular events (MACE) (relative risk [RR] 77.1%, 95% CI: 66.9%-88.2%), and all-cause mortality (RR 94.0%, 95% CI:92.4%-96.3%) under an optimistic scenario, and MACE (RR 85.5%, 95% CI: 74.7%-96.3%), and all-cause mortality (RR 95.7%, 95% CI:92.1%-98.1%) under a conservative scenario (See Table for other outcomes). The long-term use of iGlarLixi may lead to a substantial reduction in diabetes-related complications among people with T2D at elevated risk for CVD. Disclosure H. Shao: Research Support; Self; Sanofi. H. Kianmehr: None. P. Li: None. V. Fonseca: Consultant; Self; Abbott Diabetes, Asahi Kasei Corporation, Bayer Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Intarcia Therapeutics, Inc., Novo Nordisk, Pfizer Inc., Sanofi-Aventis, Stock/Shareholder; Self; Amgen Inc., Bravo4health, Mellitus Health. L. Shi: Research Support; Self; AstraZeneca, Sanofi. Funding Sanofi (2020-1487)