Sanofi announced the presentation of the results of the pivotal Phase 3 LixiLan-O and LixiLan-L clinical trials with the investigational titratable fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide in adults with type 2 diabetes.
Both studies met their primary endpoints, demonstrating statistically superior reduction of HbA1c (average blood glucose over the previous three months) with the titratable fixed-ratio combination versus comparators (lixisenatide and insulin glargine 100 Units/mL, respectively). The most frequent adverse events were nausea, vomiting and diarrhea.
Full results were presented on June 12 at the American Diabetes Association 76thScientific Sessions in New Orleans, LA, U.S. Top-line results were previously reported in Q3 of 2015.
“These studies reflect Sanofi’s commitment to innovative approaches in developing medicines intended to help patients meet their needs throughout their diabetes journey,” said Jorge Insuasty MD, Senior Vice President, Global Head of Development, Sanofi. “We look forward to continuing to work with the FDA and EMA as they complete their reviews and to receiving their decisions.”
The results of the LixiLan-O and LixiLan-L studies have been included in regulatory submissions to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), with regulatory decisions anticipated in August 2016 (FDA) and Q1 2017 (EMA).
The presentation abstracts are titled:
- • Clinical Impact of Titratable Fixed-Ratio Combination of Insulin Glargine/Lixisenatide vs. Each Component Alone in Type 2 Diabetes Inadequately Controlled on Oral Agents: LixiLan-O Trial (NCT02058147)(Rosenstock, J et al. Oral presentation 186-O, American Diabetes Association 76th Scientific Sessions, New Orleans, LA, U.S. at 8:45 a.m. on June 12, 2016).
- • Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed-Ratio Combination vs. Insulin Glargine in Patients with T2DM: the LixiLan-L Trial (NCT02058160)(Aroda, V et al. Oral presentation 238-O, American Diabetes Association 76thScientific Sessions, New Orleans, LA, U.S. at 2:30 p.m. on June 12, 2016).
- The proprietary name for the titratable fixed-ratio combination is under consideration. Its safety and efficacy have not been evaluated by any regulatory authority.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult 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.
Lixisenatide was in-licensed from Zealand Pharma A/S , 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. Lixisenatide is currently approved in over 60 countries worldwide for the treatment of adults with type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. Lixisenatide is an investigational product in the U.S.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial.