Sanofi's Lyxumia achieves primary efficacy endpoint in study of patients uncontrolled on metformin

Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that Lyxumia® (lixisenatide), a once-daily GLP-1 receptor agonist under development for type 2 diabetes, achieved its primary efficacy endpoint of significant HbA1c reduction vs. placebo in patients uncontrolled on metformin. The study objectives were to compare the efficacy and safety of lixisenatide versus placebo in one-step and two-step dose increase regimens in terms of reduction in HbA1c.

"Efficacy and Safety of Lixisenatide Once-Daily Versus Placebo in Patients with Type 2 Diabetes Insufficiently Controlled on Metformin (GetGoal-F1)" [ABSTRACT 784]

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 (10 micrograms for two weeks, then 20 micrograms); lixisenatide two-step dose increase (10 micrograms for one week, 15 micrograms for one week, then 20 micrograms), or placebo, as add on to metformin.

Top-line 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 < or = 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% versus 7.6% and 24.1% with placebo, respectively.

In addition, both one- and two-step regimens reduced body weight: one-step: -2.63kg; two-step: -2.68kg versus placebo: -1.63kg; (p-value 1-step = 0.0042; p-value 2-step = 0.0025).

"The GetGoal-F1 study shows that, in people with type 2 diabetes not achieving adequate glycemic control, lixisenatide once daily as 'add on' to metformin is effective in both improving glycemic control and reducing body weight, and the one-step dose increase regimen may be the best option for treatment initiation," said Geremia Bolli, MD, of the University of Perugia, Italy and lead investigator of the GetGoal-F1 study.

The percentage of patients who discontinued during the main 24-week treatment period due to adverse events was 5.6% in the one-step regimen, 8.1% in the two-step regimen versus 2.5% with placebo. Overall, lixisenatide was well tolerated and gastrointestinal event levels were as expected for the GLP-1 class. The most frequently reported adverse events were nausea (26.1% [1-step], 35.4% [2-step] vs. 4.4% with placebo) and vomiting (11.8% [1-step], 15.5% [2-step] vs. 0% with placebo). There was no increased risk of severe hypoglycemia.

SOURCE Sanofi