Sanofi announced that new results from a phase III study showed that the investigational product Lyxumia (lixisenatide), when used as an add-on therapy to basal insulin (in association with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c versus placebo for patients with type 2 diabetes without significantly increasing their risk of hypoglycaemia.
GetGoal-L is one of nine studies in the GetGoal phase III clinical programme, and the second trial to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin. It was a randomized (double-blind), placebo-controlled study with a 24-week main treatment period, and a total of 495 patients received either lixisenatide or placebo.
GetGoal-L showed a significant reduction in HbA1c levels (p=0.0002) with lixisenatide, without a significant increase in the incidence of symptomatic hypoglycaemia (p=0.14) versus placebo. In addition, patients treated with lixisenatide had significantly improved postprandial plasma glucose after a test meal (p<0.0001). Patients in the lixisenatide arm of the study also reported a significant reduction in body weight (p<0.0001). These results confirm those previously reported on GetGoal-L Asia, this time in a broader population including both Caucasian and Asian patients. As expected with a GLP-1, the most commonly reported adverse event with lixisenatide was nausea with a low rate of discontinuation.
“These positive efficacy and safety results are another important milestone in the GetGoal clinical trial program and show the potential value of adding Lyxumia (lixisenatide) to basal insulin to improve glycaemic control,” said Pierre Chancel, senior vice president, Global Diabetes Division at Sanofi. “The findings from this and previous studies reinforce a continuing positive trend demonstrating the potential of lixisenatide to improve the lives of people with type 2 diabetes.”
The full study results from GetGoal-L are planned to be presented at a medical congress.
Lixisenatide, a Glucagon-Like Peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was in-licensed from Zealand Pharma A/S (Copenhagen, Denmark).
GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes, and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.
The GetGoal phase III clinical programme will provide data for the efficacy and safety of lixisenatide in adults with type 2 diabetes treated with various oral anti-diabetic agents or insulin. With nine trials in the programme, GetGoal started in May 2008 and has enrolled more than 4300 patients. To date GetGoal-X, GetGoal-Mono, GetGoal-L Asia and GetGoal-S have reported positive top-line results supporting efficacy and safety for lixisenatide. Further results are expected during 2011.
Sanofi strives to help people manage the complex challenges of diabetes by delivering innovative, integrated and personalized solutions. Driven by valuable insight that comes from listening to and engaging with people living with diabetes, the company is forming partnerships to offer diagnostics, therapies, services, and devices, including innovative blood glucose monitoring systems.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs and has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health.