Global healthcare leader Sanofi has announced the full results of the phase 3 trials for investigational titratable fixed ratio combination of insulin glargine and lixisenatide in patients with type 2 diabetes.
Phase 3 trials involve the study of the drug's effectiveness, safety, side effects and comparison with commonly used treatments.
‘Sanofi announced positive results of Phase 3 clinical trials for diabetic drug Lixilan, a combination of basal glargine with glucagon like peptide 1 (GLP-1) lixisenatide. The results are now submitted to regulatory agencies for its approval.’
The presentation mainly focused on the two main studies which was on the titratable fixed dose combination of glargine with lixisenatide in patients with type 2 diabetes who were on treatment with oral hypoglycemic drug metformin (Lixilan O trial) and the other on efficacy and safety of the combination of glargine with lixisenatide compared with glargine in patients with type 2 diabetes ( Lixilan L trial).
The results of both the studies were presented at the American Diabetes Association 76th Scientific Sessions in New Orleans, LA, U.S on June 12th 2016. The results were found to show a superior decrease in the HbA1c level with the titratable fixed ratio combination and comparators (lixenatide and insulin glargine). The adverse effects noted were nausea, vomiting and diarrhea.
Jorge Insuasty MD, Senior Vice President of Sanofi stated that these studies tend to prove that Sanofi is committed to develop medicines with an innovative approach for the treatment of diabetes. He also said that the company will continue to work with regulatory agencies like Food and Drug Administration (FDA) and European Medicines Agency (EMA) to receive their approval.
Lixilan is a single injection combination of basal insulin glargine with glucagon like Peptide (GLP-1 ) lixisenatide and is used for the treatment of type 2 diabetes. It is found to be a tough competitor for xultophy from Novo Nordisk which is a combination of basal insulin Tresiba with glucagon like peptide (GLP-1) victoza.
The regulatory decisions of the Food and Drug Administration (FDA) and European Medicines Agency (EMA) are expected in August 2016 and Q1 2017 respectively for lixilan prior to the drug xultophy which is to be approved in the month of September 2016.