Zealand Pharma: Additional positive Phase III results with Lyxumia (lixisenatide) for the treatment of Type 2 diabetes

01-Jun-2011 - Denmark

Zealand Pharma A/S announced that its partner, Sanofi has released additional positive results from the global GetGoal Phase III development program with Lyxumia® (lixisenatide) for the treatment of type 2 diabetes. Lixisenatide was invented by Zealand Pharma and global rights are with Sanofi.

Top-line results from the GetGoal-L study showed that lixisenatide as an add-on therapy to basal insulin (with or without metformin), achieved its primary efficacy endpoint of significantly reducing HbA1c levels (p=0.0002) without significantly increasing the risk of hypoglycemia (p=0.14) versus placebo for patients with Type 2 diabetes. 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). The trial was a randomized (double-blind), placebo-controlled study with a 24-week main treatment period and comprising a total of 495 patients.

As expected with a GLP-1 drug, the most commonly reported adverse event with lixisenatide was nausea, which was associated with a low rate of discontinuation.

GetGoal-L is the fifth of nine studies to report positive data within the GetGoal Phase III clinical program, and the second study after GetGoal-L Asia to investigate the benefits of lixisenatide 20µg once-daily combined with basal insulin, including Lantus®. The results confirm those previously reported, and this time in a broader population including both Caucasian and Asian patients.

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

https://www.bionity.com/en/news/132772/zealand-pharma-additional-positive-phase-iii-results-with-lyxumia-lixisenatide-for-the-treatment-of-type-2-diabetes.html