Sanofi recently announced that its Phase III clinical trial called LixiLan-L, assessing the safety and efficacy of the fixed ratio combination of insulin glargine (100 Units/mL) and lixisenatide in patients with type 2 diabetes, met its primary goal.
Type 2 diabetes is the most common form of diabetes, affecting 90 to 95% of the individuals diagnosed with the disease. Type 2 diabetes patients do not make enough insulin or do not use it properly, leading to insulin resistance and eventually to higher blood sugar levels (hyperglycemia). Insulin is a hormone essential to controlling blood sugar levels and converting sugar, starches and other foods into energy.
Insulin glargine injection, or Lantus, is a long-acting insulin for the control of high blood sugar prescribed for the treatment of adults with type 2 diabetes, and adults and children 6 years and older with type 1 diabetes. Sanofi notes that Lantus should be taken once daily, at the same time every day. Lixisenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist currently approved in more than 60 countries worldwide as a therapy for type 2 diabetes in adults, and is an investigational therapeutic product in the United States.
In the LixiLan-L trial, the drug combination insulin glargine/lixisenatide was compared to treatment with insulin glargine (100 Units/mL) alone over a 30-week period. In total, 736 type 2 diabetes patients enrolled in the study; all patients had uncontrolled diabetes (unable to maintain an adequate glycemic control) despite the use of insulin or insulin combined with one or two oral anti-diabetic agents.
Researchers found that the fixed-ratio combination of insulin glargine/lixisenatide therapy resulted in a superior significant reduction in HbA1c (the average patient’s blood glucose over the previous three months) in comparison to treatment with insulin glargine alone. In terms of safety, the overall profile of the fixed-ratio combination was similar to the one of insulin glargine (100 Units/mL) and lixisenatide.
“This study examined an important possible use of this investigational medicine,” said the Executive Director, International Diabetes Center at Park Nicollet, Minneapolis, Dr. Richard M. Bergenstal in a press release. “The result highlights that this could provide a treatment option for the roughly fifty percent of patients who are no longer able to remain at their HbA1c target, despite basal insulin treatment.”
“The Phase III LixiLan-O and LixiLan-L clinical trials were initiated at the beginning of 2014 to explore the safety and efficacy of our investigational fixed-ratio combination when used before and after basal insulin, respectively,” said the President of Global R&D at Sanofi, Dr. Elias Zerhouni. “These studies reflect Sanofi’s commitment to developing and evaluating medicines intended to meet patient needs throughout their journey with diabetes.”
Sanofi reported that the complete results of the LixiLan-L trial will be disclosed in a future scientific forum.