Sanofi-Aventis has announced that Lixisenatide ( Lyxumia ) once-daily achieved primary efficacy endpoint and fewer hypoglycemias versus Exenatide ( Byetta ) twice-daily.
The GetGoal-X Phase III study of Lixisenatide, a once-daily GLP-1 receptor agonist, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with Exenatide twice-daily.
In addition, the initial results have shown that significantly fewer people with type 2 diabetes treated with Lixisenatide once-daily reported hypoglycemic events versus patients treated with Exenatide.
In the Lixisenatide arm, three-fold fewer people reported symptomatic hypoglycemia than people who were on Exenatide ( 2.5% vs 7.9%; p less than 0.05 ).
Six-fold fewer hypoglycemia events were observed in patients on Lixisenatide than those treated with Exenatide ( 8 vs 48 events ).
Other endpoints were broadly consistent with what has been observed with other GLP-1 agonists.
The GetGoal-X clinical trial is a randomized, open-label, active-controlled, two-arm parallel-group, multicenter study, with a 24-week main treatment period. It compared the efficacy and safety of the two GLP-1 receptor agonists: once-daily Lixisenatide versus twice-daily Exenatide as add-on therapy for people with type 2 diabetes whose condition is inadequately controlled by Metformin.
A total of 639 people were randomized to receive either Lixisenatide or Exenatide. Both groups have received a stepwise increase in dose, up to a maximum daily dose of 20 mcg.
Lixisenatide, a glucagon-like peptide-1 agonist ( GLP-1 ), is in development for the treatment of patients with type 2 diabetes mellitus.
The efficacy and safety of lixisenatide once-daily is being assessed in the GetGoal phase III clinical trial program. The GetGoal clinical trial program started in May 2008 and has enrolled more than 4,500 patients.
GetGoal-X is one of nine in the GetGoal phase III study Program, which involves more than 4300 people with diabetes mellitus. The enrollment of the eight other studies of the GetGoal Phase III program assessing efficacy and safety of Lixisenatide in adult patients with type 2 diabetes mellitus treated with various oral antidiabetic agents or Insulin was completed at the end of 2009.
GLP-1 is a naturally occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells.
GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes. ( Xagena )
Source: Sanofi-Aventis, 2012