French multinational company Sanofi announced on Monday Sept 14 that its new type 2 diabetes drug called LixiLan has showed promising results during its Phase III clinical trial. With this, the company is preparing for the regulatory reviews in the United States and in the European Union come the fourth quarter of 2015 and the first quarter of 2016 respectively.
LixiLan is an injectable drug that combines 100 unit/mL of insulin glargine (Lantus) and lixisenatide (Lyxumia), a glucagon-like peptide 1 (GLP-1) receptor agonist. Both drugs are long-acting medications for type 2 diabetes patients. Lantus is from Sanofi while Lyxumia was in-licensed from Zealand Pharma.
By administering both drugs via one injectable preparation, which is LixiLan, the levels of HbA1c or the average level of blood glucose in the past three months, exhibited a more drastic decline, compared to the administration of Lantus alone. The safety profile of the combined drug also reflected that of both Lantus and Lyxumia.
"This study examined an important possible use of this investigational medicine," said Richard M Bergenstal MD, Executive Director of the US International Diabetes Center in Minnesota. With the findings of the clinical trial, new treatment choices for patients who are not able to maintain normal HbA1c levels despite the administration of basal insulin remedies, may now be presented. According to the Bergenstal, about fifty percent of patients do not longer respond to basic insulin treatments.
The Phase III clinical trial, dubbed as LixiLan-L, involved 736 study participants diagnosed with type 2 diabetes that is uncontrolled by one or two oral basal insulin therapies upon screening. They were subjected to a 30-week study that tested the safety and efficacy of the combined drug versus 100 Units/mL of Lantus alone. Patients who were then currently taking metformin were also asked to continue with their practice during the entire course of the trial.
LixiLan-O, which is the initial part of the Phase III study, also exhibited positive results as announced by Sanofi in July 2015. Specifically, LixiLan was able to demonstrate that it can notably decrease the levels of HbA1c within 30 weeks in 1,170 participants diagnosed with type 2 diabetes who do not respond to metformin-only and combined metformin/anti-diabetic drug therapies.
Sanofi is looking at presenting the full details of the LixiLan-O and LixiLan-L results in a scientific forum in the future.