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Daily lixisenatide improved glycemic control in GetGoal trials

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ADA 71st Scientific Sessions

SAN DIEGO — Results from two studies examining lixisenatide, a developmental, once-daily glucagon-like peptide 1 receptor agonist, demonstrated non-inferiority in HbA1c reduction with less symptomatic hypoglycemia and improved glycemic control in patients with type 2 diabetes.

Once-daily lixisenatide (Lyxumia, Sanofi) was tested in GetGoal-X, a randomized, open-label, active-controlled, two-arm, parallel-group, multicenter study. The study included a 24-week treatment period with lixisenatide or exenatide (Byetta, Amylin) in 634 patients with type 2 diabetes who were insufficiently controlled on metformin ≥1.5 g/day. Both groups received a stepwise increase in dose, up to a maximum daily dose of 20 mcg.

The primary endpoint — non-inferiority of lixisenatide vs. exenatide on HbA1c — was achieved (change from baseline: –0.79 vs. –0.96), and lixisenatide was also associated with improvements in mean fasting plasma glucose (change from baseline: –22.0 vs. –26.1). Mean body weight decreased significantly from baseline in the lixisenatide group compared with exenatide (94.5 to 91.7 kg vs. 96.7 to 92.9 kg). Additionally, symptomatic hypoglycemia occurred among fewer patients in the lixisenatide group compared with exenatide (2.5% vs. 7.9%; P<.05).

A second study of once-daily lixisenatide in Asian patients with type 2 diabetes who were insufficiently controlled with basal insulin with or without sulfonylurea demonstrated improved glycemic control as compared with placebo.

GetGoal-L Asia — a 24-week, randomized, double blind, placebo-controlled, two-arm, multicenter, phase 3 study — included 311 patients assigned to 20 mcg lixisenatide or placebo. Treatment with lixisenatide was associated with a significant improvement in HbA1c vs. placebo (mean difference: –0.9%), and a higher percentages of patients achieved HbA1c levels ≤6.5% (17.8% for treatment vs. 1.3% for placebo) and <7% (35.6% for treatment vs. 5.2% for placebo; P<.0001).

Compared with placebo, lixisenatide treatment was also associated with improvements in 2-hour postprandial glucose, glucose excursion and average seven-point self-measured plasma glucose (P<.0001 for all).

In both studies, lixisenatide was well-tolerated and the occurrence of serious adverse events was comparable between treatment groups. Discontinued due to adverse events was primarily related to gastrointestinal issues such as nausea, diarrhea and vomiting in all treatment arms studied. In the lixisenatide vs. exenatide study, sixfold fewer hypoglycemic events were reported with lixisenatide. In the GetGoal-L Asia study, hypoglycemia was more common with lixisenatide vs. placebo, as is expected in an insulin plus sulfonylurea-treated population. – by Stacey L. Fisher

For more information:

• Rosenstock J. 0033-LB.
• Seino Y. 0278-OR. Presented at: American Diabetes Association’s 71st Scientific Sessions; June 24-28, 2011; San Diego, Calif.

Disclosures: The studies were funded by Sanofi.

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