(RTTNews.com) - Sanofi (SNYNF, SNY) said Saturday that Lyxumia or lixisenatide met all co-primary endpoints in a clinical trial (GetGoal Duo-2) comparing its use as a once-daily add-on to basal insulin versus the addition of rapid acting insulin injected once each day at main meal (basal-plus) or three times daily at each meal (basal-bolus). Participants were adults with type 2 diabetes poorly controlled on basal insulin.
Lixisenatide was shown to be non-inferior to both comparator insulin regimens for reduction in blood sugar (HbA1c) and statistically superior to basal-bolus for body weight change, as co-primary endpoints for the study.
The study also showed that documented hypoglycemia was numerically lower in the lixisenatide group versus the group receiving rapid acting insulin once each day and significantly lower versus the group receiving rapid acting insulin three times each day.
Lixisenatide is a once-daily prandial glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.