Sanofi US reports positive data from Phase 3 studies of type 2 diabetes drug

23rd June 2013 (Last Updated June 23rd, 2013 18:30)

Sanofi US has reported positive pooled analysis data from three Phase 3 studies of once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA), Lixisenatide, to treat type 2 diabetes mellitus.

Sanofi US has reported positive pooled analysis data from three Phase 3 studies of once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA), Lixisenatide, to treat type 2 diabetes mellitus.

In the three Phase 3 studies, GetGoal-L, GetGoal-L Asia and GetGoal Duo1, Lixisenatide was shown to decrease HbA1c by reducing postprandial glucose (PPG) when added to basal insulin with or without oral anti-diabetic agents (OADs).

"This analysis suggests that once-daily lixisenatide complements the effects of basal insulin on glycemic control mainly by reducing after-meal glucose levels."

Principal investigator Dr Matthew Riddle, professor of medicine at the Oregon Health & Science University Endocrinology, Diabetes and Clinical Nutrition division, said, "This analysis suggests that once-daily lixisenatide complements the effects of basal insulin on glycemic control mainly by reducing after-meal glucose levels."

In order to quantify the effects of lixisenatide on fasting plasma glucose (FPG) and PPG, about 753 patients were randomised in the studies with either once-daily lixisenatide along with standard of care or placebo along with standard of care.

Following a 24-week treatment, adjusted LS mean HbA1c (average blood sugar levels for the past two to three months) change with lixisenatide plus standard of care was -0.77% against -0.29% with placebo plus standard of care.

With similar reductions in BHG exposure between the groups, the decrease in PPG exposure was more with lixisenatide plus standard of care compared with placebo plus standard of care.

The most common adverse events noted were nausea, vomiting, diarrhoea and symptomatic hypoglycemia.

Sanofi US diabetes patient centred unit vice president and head Dennis Urbaniak said, "We are encouraged by these results that suggest the potential for lixisenatide to be the first once-daily prandial GLP-1 receptor agonist for the treatment of adults with type 2 diabetes in the US."