PARIS (dpa-AFX) - Sanofi (SNY) announced that the first Phase 3 study results (EDITION I) for its investigational new insulin U300 showed equivalent blood sugar control with fewer night-time low blood sugar events compared to Lantus (insulin glargine [rDNA origin] injection).
The company also announced topline results of a second Phase 3 study (EDITION II) for new insulin U300 that also demonstrated similar blood sugar reduction while fewer patients experienced night-time low blood sugar events compared with Lantus.
These results are from EDITION I and EDITION II respectively and are part of the EDITION Phase 3 clinical program evaluating the efficacy and safety of the investigational new insulin U300 in people with diabetes.
In a separate press release, Sanofi nnounced 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.
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.
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