PARIS, June 11, 2014 /PRNewswire/ -- Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that new data on U300, Lyxumia® (lixisenatide) and Lantus® will be presented at the American Diabetes Association (ADA) 74th Scientific Sessions in San Francisco, June 13‒17. Abstracts are available on the ADA website.
Eight abstracts from the EDITION Phase III program for U300 will be presented. The worldwide and comprehensive EDITION program evaluated, in broad and diverse populations of people with diabetes, the efficacy and safety of U300 vs. Lantus®. Following presentation of EDITION I[1] and II[2] results in 2013, a meta-analysis of EDITION I/II/III; full results from the other four studies in the EDITION program; and year one results from EDITION I and II showing the first longer-term data for U300, will be presented at ADA 2014.
More than 55 additional abstracts from across the Sanofi Diabetes portfolio will also be presented. Data highlights from lixisenatide, the fixed-ratio combination of lixisenatide and Lantus®, Lantus®, and the TEENs study are listed below.
Data highlights
Abstract # 90-LB: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in a Meta-analysis of Phase 3a EDITION Clinical Trials in People with T2DM
Abstract # 68-OR: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in Insulin Naïve People with T2DM (EDITION 3)
Abstract # 80-LB: Glycemic Control and Hypoglycemia with New Insulin Glargine 300U/mL in People with T1DM (EDITION 4)
Abstract # 88-LB: New Insulin Glargine 300 U/mL: Glycemic Control and Hypoglycemia in Japanese People with T1DM (EDITION JP 1)
Abstract # 94-LB: Glycemic Control and Hypoglycemia in Japanese People with T2DM Receiving New Insulin Glargine 300 U/mL in Combination with OADs (EDITION JP 2)
Abstract # 81-LB: Sustained Glycemic Control and Less Hypoglycemia with New Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in People with T2DM Using Basal + Mealtime Insulin (EDITION 1)
Abstract # 93-LB: Less Nocturnal Hypoglycemia and Weight Gain with New Insulin Glargine 300 U/mL Compared with 100 U/mL: 1-Year Results in People with T2DM Using Basal Insulin with OADs (EDITION 2)
Abstract # 892-P: Low Within- and Between-Day Variability in Exposure to New Insulin Glargine 300 U/mL
Abstract # 919-P: New Insulin Glargine 300 U/mL: Efficacy and Safety of Adaptable vs. Fixed Dosing Intervals in People with T2DM
Data highlights
16 abstracts (including 1 publication-only) will be presented on lixisenatide, including:
Abstract # 1017-P: Effect of Lixisenatide vs. Liraglutide on Glycemic Control, Gastric Emptying, and Safety Parameters in Optimized Insulin Glargine T2DM ± Metformin
Abstract # 118-LB: Effectiveness of Lixisenatide Before Breakfast or the Main Meal Using CGM with AGP Analysis
2 abstracts will be presented on the fixed-ratio combination of lixisenatide and Lantus®, including:
Abstract # 332-OR: Benefits of a Fixed-Ratio Formulation of Once-Daily Insulin Glargine/Lixisenatide (LixiLan) vs. Glargine in Type 2 Diabetes (T2DM) Inadequately Controlled on Metformin
27 abstracts will be presented on Lantus®, including:
Abstract # 6-LB: Enhanced Prediction of Cardiovascular Events By Adding Novel Biomarkers to Clinical Risk Factors in the ORIGIN Trial
3 abstracts for the first global presentation of the TEENs study results will be presented, including:
Abstract # 32-OR: Global Assessment of Factors Associated with Target Glycemic Control in Youth with Type 1 Diabetes (T1D): the TEENs Study