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Sanofi's type 2 diabetes drug achieves main goal of phase 3 trial

Published: 16:06 12 Sep 2011 BST

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European drug maker Sanofi (NYSE:SNY) announced Monday the phase three trial of its Lyxumia drug for the treatment of adult type two diabetes met the primary endpoint, proving safety and efficacy.

The Lyxumia drug uses lixisenatide, a once-daily injectable glucagon-like peptide-1 (GLP-1) receptor.

The GLP-1 receptor works by binding to the peptide to stimulate the production and secretion of insulin, while also suppressing the production and secretion of glucagon, equalizing the sugar levels in the blood, and controlling diabetes.

Type 2 diabetes is a metabolic disorder characterized by high levels of glucose, or sugar, in the blood. Often affecting over-weight and inactive individuals, the disease causes frequent urination, increased thirst and hunger, and fatigue, and has also been linked to early-onset Alzheimer's disease.

The randomized, double-blind, placebo-controlled, multi-centre GetGoal-F1 trial, one of nine clinical studies in the GetGoal program, enrolled 482 adults with type 2 diabetes.

Top line results found that the Lyxumia drug reduced baseline levels of HbA1c, an indicator of blood sugar levels, while also reducing patient body weight.

Patients were treated over a 24-week period with either a one-step dose increase of Lyxumia, which involves a 10 microgram (ug) dose for two weeks and a 20 ug dose for the remaining 22 weeks, or a two-step Lyxumia dosing system, involving 10 ug for one week, followed by 15 ug for one week, and 20 ug for the remaining 22 weeks, or a placebo.

All patients were also treated with metformin, a traditional type 2 diabetes drug.

"The GetGoal-F1 study shows that, in people with type 2 diabetes not achieving adequate glycemic control, lixisenatide once daily as 'add on' to metformin is effective in both improving glycemic control and reducing body weight, and the one-step dose increase regimen may be the best option for treatment initiation," said Geremia Bolli, lead investigator of the clinical trial.

The results of this study will be presented at the 47th annual meeting of the European Association for the Study of Diabetes. Further results from other GetGoal program trials are expected during 2011.

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