Sanofi US (EURONEXT: SAN and NYSE: SNY) announced today data that showed lixisenatide, an investigational once-daily prandial glucagon-like peptide 1 (GLP-1) receptor agonist, decreased HbA1c by reducing PPG (postprandial glucose) daytime exposure when added to standard of care which includes basal insulin with or without oral anti-diabetic agents (OADs). Lixisenatide is for the treatment of adults with type 2 diabetes mellitus. This data was presented at the American Diabetes Association 73rd Scientific Sessions in Chicago.
The pooled analysis included data of 753 patients from three randomized Phase 3 studies of either once-daily lixisenatide plus standard of care versus placebo plus standard of care to quantify the effects of lixisenatide on FPG (fasting plasma glucose) and PPG. FPG and PPG are the levels of glucose in a patient's blood with an empty stomach (fasting) and after a meal (postprandial), respectively.
"Basal insulin can control overnight glucose for people living with type 2 diabetes, but HbA1c levels may remain high due to persisting high levels of glucose during the day," said principal investigator Matthew Riddle, M.D. Professor of Medicine in the Division of Endocrinology, Diabetes & Clinical Nutrition at Oregon Health & Science University, U.S. "This analysis suggests that once-daily lixisenatide complements the effects of basal insulin on glycemic control mainly by reducing after-meal glucose levels."
After 24 weeks of treatment, adjusted LS mean HbA1c -- average blood sugar levels for the past two to three months -- change was -0.77% with lixisenatide plus standard of care compared with -0.29% with placebo plus standard of care (p<0.0001). The reduction in BHG exposure between lixisenatide plus standard of care and placebo plus standard of care were similar (adjusted LS mean change for AUC24h -234 mg/dl*h vs. -198 mg/dl*h [NS]), but PPG exposure was reduced more with lixisenatide plus standard of care compared with placebo plus standard of care (adjusted LS mean change -378 mg/dl*h vs. -180 mg/dl *h, p<0.0001).
The three Phase 3 studies included in this analysis were part of the GetGoal clinical program and included GetGoal-L, GetGoal-L Asia and GetGoal Duo1. The most common adverse events were nausea, vomiting, diarrhea and symptomatic hypoglycemia which are detailed in the following chart.
* Sulfonylurea added to lixisenatide plus basal insulin
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