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Lyxumia demonstrates noninferiority to Byetta in late-stage trial

PARIS — An investigational Sanofi drug for diabetes works at least as well as a similar treatment already on the market, and results in less abnormally low blood sugar, according to late-stage clinical trial results presented at the American Diabetes Association’s 71st Scientific Sessions in San Diego this past weekend.

Sanofi said the drug Lyxumia (lixisenatide) demonstrated noninferiority to Byetta (exenatide), made by Eli Lilly and Amylin Pharmaceuticals, and less hypoglycemia in a phase-3 trial. The trial included 634 patients who received either Lyxumia once per day or Byetta twice per day in addition to the generic diabetes drug metformin.

Other findings included greater reduction in weight and fewer patients having to stop therapy due to such adverse side effects as nausea, diarrhea and vomiting.

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Sanofi presents study data at American Diabetes Association’s 71st Scientific Sessions

PARIS — A new study indicated that two insulin products made by French drug maker Sanofi lower blood-glucose levels to a greater extent than premixed insulin, and with improvements in quality of life and less hypoglycemia.

Sanofi announced results of the 60-week study, which compared regimens, including Lantus (insulin glargine [rDNA origin]) and Apidra (insulin glulisine [rDNA origin]).

“Optimization of insulin dosage with glargine plus a single mealtime injection of glulisine allowed more patients to reach target A1C levels than with twice-daily premixed insulin, and with less hypoglycemia,” Oregon Health and Science University section head for diabetes and study investigator Matthew Riddle said. “These findings support a stepwise approach to addition of mealtime insulin when basal insulin with oral agents is not sufficient to maintain control.”

Three analyses of data from the study were published or presented at the American Diabetes Association’s 71st Scientific Sessions in San Diego.