French drugmaker Sanofi (SNY) Tuesday reported positive results for once-daily lyxumia in combination with lantus in type 2 diabetes uncontrolled on oral anti-diabetics, mainly metformin. Results also showed a significant improvement in post-prandial glucose.
Lyxumia or lixisenatide is an investigational glucagon-like peptide-1 agonist in development for the treatment of patients with type 2 diabetes mellitus.
The double-blind, placebo-controlled GetGoal Duo 1study included a 12-week run-in period with lantus, or insulin glargine, initiated and titrated to reach a target fasting plasma glucose of 80-100 mg/dL.
This was followed by a 24-week randomized period where 446 patients with glycated hemoglobin, or
HbA1c, more than 7 percent received lixisenatide once-daily or placebo while insulin glargine and metformin were continued.
During the run-in period, HbA1c decreased on average to 7.60 percent from 8.60 percent. After randomization, the addition of lixisenatide led to a greater decrease in HbA1c to a mean value of 6.96 percent , compared to placebo, after 24 weeks. Lixisenatide also significantly improved 2-h post-prandial glucose compared to placebo.
The most common adverse events observed in the study were mild and transient nausea and vomiting.
The European Medicines Agency on November 16 accepted Sanofi's marketing authorization application filed for lyxumia. Submission for regulatory approval in the U.S. is expected in the fourth quarter of 2012.
SNY closed on Monday at $34.24, down $0.25 or 0.72 percent, on 2.55 million shares.
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