Sanofi announced data from its Phase 3 study of Lyxumia (lixisenatide) for the treatment of type 2 diabetes mellitus. The GetGoal-F1 trial, one of nine studies in the GetGoal clinical program, was a randomized, double-blind, placebo-controlled, parallel group, multicenter study with a 24-week main treatment period. A total of 482 people with type 2 diabetes were randomized and exposed to one of the following once-daily regimens: lixisenatide one-step dose increase (10mcg for two weeks, then 20mcg); lixisenatide two-step dose increase (10mcg for one week, 15mcg for one week, then 20mcg), or placebo, as add on to metformin.
Results show that lixisenatide significantly reduces HbA1c from baseline to Week 24 in both treatment regimens, compared with placebo (one-step: -0.92%; two-step: -0.83% vs. placebo: -0.42%; P<0.0001). The percentage of patients reaching HbA1c targets of ≤6.5% and HbA1c <7.0% with the one-step regimen was 25.6% and 47.4% and with the two-step regimen was 20.4% and 42.1% vs. 7.6% and 24.1% with placebo, respectively.
Lixisenatide is a glucagon-like peptide-1 agonist (GLP-1).
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