Once-a-day lixisenatide reduces HbA1c levels in diabetes: sanofi-aventis

Lixisenatide, an investigational once-a-day drug therapy by sanofi-aventis, has been found successful in cutting down HbA1c levels during late phase clinical studies in diabetes patients.

Results of the study of the GetGoal Phase III clinical trial program showed lixisenatide (AVE0010), a once-daily GLP-1 agonist, significantly reduced HbA1c vs. placebo with more patients achieving HbA1c more than 7% and improved glycemic control in adult patients with type 2 diabetes, sanofi-aventis said in a press release.

“Developing new diabetes treatments, like lixisenatide, and helping patients achieve diabetes control is paramount to tackling the growing diabetes epidemic,” stated Dr. Marc Cluzel, executive vice-president, R&D,sanofi-aventis.

sanofi plans to announce full results from the first Phase III study oflixisenatide later in the year.

The 12-week study involved 361 patients with type 2 diabetes not currently receiving glucose-lowering therapy and with HbA1c between 7 and 10%. Patients were randomized to one of four once-daily treatment regimens: lixisenatide two-step titration and lixisenatide one-step titration, placebo two-step titration, or placebo one-step titration.

HbA1c was significantly reduced in both lixisenatide titration groups versus placebo, and significantly more patients in the lixisenatide groups achieved HbA1c less than 7% (46.5 to 52.2% versus 26.8%).

Lixisenatide also significantly improved fasting plasma glucose and two-hour post-prandial glucose with a pronounced decrease in 2-hour post-prandial glucose excursion.

Lixisenatide was generally well tolerated.

The Phase III GetGoal clinical trial program for lixisenatide started in May 2008. It is designed as multicentre,randomized placebo or active-controlled studies and has enrolled more than 4500 patients. The enrollment of the eight other studies of the GetGoal Phase III program assessing efficacy and safety of lixisenatide in adult patients with type 2 diabetes mellitus treated with various oral antidiabetic agents or insulin was completed atthe end of 2009.

A phase III program with the combination of lixisenatide / Lantus (insulin glargine [rDNA]
injection) is expected to start later this year.

The complete study findings have been submitted for presentation at the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD), in Stockholm, Sweden, in September 2010.

Diabetes is a chronic, widespread condition in which the body does not produce or properly use insulin, the hormone needed to transport glucose (sugar) from the blood into the cells of the body for energy.

More than 230 million people worldwide are living with the disease and this number is expected to rise to a staggering 350 million within 20 years. It is estimated that nearly 24 million Americans have diabetes, including an estimated 5.7 million who remain undiagnosed.

At the same time, about 40 percent of those diagnosed are not achieving the blood sugar control target of HbA1c less than 7 percent recommended by the ADA.

The HbA1c test measures average blood glucose levels over the past two- to three-month period.

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutics.