GOOOOOOOAAAAALLLLL!!!!!!! Interim Results Promising for Lixisenatide

December 7, 2011

written by Michael O’Leary

More people with type 2 diabetes using insulin and metformin who have trouble keeping their blood glucose below 8 percent are able to reach their goal if they take lixisenatide with insulin and metformin.

That’s the interim result of the GetGoal Duo 1 study announced today in a press release by Sanofi Aventis, which has the marketing rights to the drug made by Zealand Pharma. (Link to published site)

In the recently completed Phase III GetGoal Duo1 study, 446 patients with HbA1c higher than 7 percent despite controlled fasting blood glucose after 12 weeks of treatment with insulin were randomly assigned to receive either lixisenatide once a day or placebo while continuing to take insulin and metformin.

During the 12-week insulin-only period, patients’ HbA1c decreased on average from 8.60 percent to 7.60 percent.

At the end of the 24 weeks, 56.3 percent of the group taking lixisenatide achieved blood sugar levels averaging 6.96 percent, compared to only 38.5 percent of those who received the placebo.

Lixisenatide also significantly improved the blood glucose levels two hours after eating with an average difference of -3.16 mmol/L compared to those on placebo. People in the lixisenatide group also lost on average about one pound more than those who received placebo.

Lixisenatide is one of a new class of drugs called GLP-1 blockers. GLP-1 is short for glucon-like peptide-1 and plays a role in controlling glucose in the blood and curbing the appetite. GLP-1 stimulates the release of insulin when glucose levels become too high. Sanofi intends to market lixisenatide under the trade name Lyxumia® to compete with Byetta®, a GLP-1 blocker made by Eli Lilly and Company.

People in the study experienced the same side effects that have been seen with other GLP-1 blockers. The most common were mild nausea and vomiting that went away over time. A total of 50 patients (22.4 percent) treated with lixisenatide and 30 patients (13.5 percent) in the placebo group reported low blood-sugar events as defined in the study design during the treatment period.

On Nov. 16 2011, the European Medicines Agency (EMA) approved lixisenatide (Lyxumia®) for sale in the European Union. The company plans to submit its application for FDA approval of lixisenatide in the United States at then end of 2012.