PARIS, France, June 10, 2014 /PRNewswire/ --
- New results for Toujeo(R)(insulin glargine [rDNA origin] injection, 300 U/mL; "U300") from EDITION I/II/III meta-analysis, EDITION III, IV, JP 1 and JP 2 studies
are among over 65 abstracts to be presented -
Sanofi announced today that new data on U300, Lyxumia(R) (lixisenatide) and Lantus(R) 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 [http://professional.diabetes.org/Congres... ].
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(R). 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(R), Lantus(R), 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 Naive 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
plus or minus 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(R), 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(R), 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
About Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL)
Toujeo(R) (insulin glargine [rDNA origin] injection, 300 U/mL; "U300") is a new basal insulin currently in development for the treatment of people with diabetes mellitus. U300 has a pharmacokinetic and pharmacodynamic profile with studies demonstrating it is smoother and more prolonged than Lantus(R).[3-6] Toujeo(R) is the intended trade name for U300. U300 is not currently approved or licensed anywhere in the world.
About Lyxumia(R) (lixisenatide)
Lyxumia(R) (lixisenatide) is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.
Lyxumia was in-licensed from Zealand Pharma A/S , http://www.zealandpharma.com and was approved in Europe in 2013 for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is currently approved in over 40 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in Europe, Japan, Mexico and other markets. Sanofi plans to resubmit the New Drug Application for lixisenatide in the United States in 2015, after completion of the ELIXA cardiovascular outcomes study. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide.
The Lyxumia pen is the winner of the Good Design Award 2012 and the iF Product Design Award. The variant of the Lyxumia pen used in Japan won the Good Design Award (G Mark) 2013.
About Sanofi Diabetes
Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insights that come from listening to and engaging with people living with diabetes, the Company is forming partnerships to offer diagnostics, therapies, services, and devices including blood glucose monitoring systems. Sanofi markets both injectable and oral medications for people with type 1 or type 2 diabetes.
About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris and in New York .
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