Sanofi announced today 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 hypoglycemia.

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 randomised (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 hypoglycemia (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.

Professor A H. Barnett, Professor of Medicine and Clinical Director at Heartlands Hospital, Birmingham, commented: "These results are encouraging and highlight the potential value of adding lixisenatide to basal insulin to improve glycemic control. They are another important milestone in the GetGoal clinical trial programme and the findings from the programme so far suggest that lixisenatide has the potential to be an important new therapy for patients with Type 2 diabetes."

The full study results from GetGoal-L are planned to be presented at a medical congress.

Notes

About Lixisenatide (AVE 0010)

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). Lixisenatide has not yet been licensed for use by any regulatory body.

About GLP-1 Receptor Agonists

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.

About the GetGoal Phase III Clinical Programme The GetGoal Phase III clinical programme is providing expanding evidence 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 4,300 patients. To date GetGoal-X, GetGoal-Mono and GetGoal-L Asia have reported positive top-line results supporting efficacy and safety for lixisenatide. Further results are expected during 2011.

About the sanofi-aventis Diabetes Division

Sanofi-aventis strives to deliver innovative and integrated patient-focused solutions for people living with diabetes. The Company currently has insulin products that are also available in injection pens for people with Type 1 or Type 2 diabetes, as well as an oral, once-daily sulfonylurea treatment for Type 2 diabetes. In order to provide comprehensive care in diabetes management, sanofi-aventis also provides innovative blood glucose monitoring systems. Investigational compounds in the pipeline include the potential first regenerative treatment for diabetes as well as a once-daily injectable GLP-1 agonist to be used alone, in combination with basal insulins, and/or in combination with oral anti-diabetic agents.

Source:
Sanofi-aventis