The efficacy and safety of Lixisenatide ( Lyxumia ), a once-daily prandial glucagon-like peptide-1 ( GLP-1 ) receptor agonist, in older patients with type 2 diabetes mellitus ( T2DM ) insufficiently controlled on oral antidiabetic were evaluated.
A meta-analysis was conducted on data from older patients ( greater than or equal to 65 years ) from five of the GetGoal trials, in which patients with type 2 diabetes mellitus were treated with Lixisenatide 20 mcg once daily or placebo, as an add-on to oral antidiabetics.
The primary endpoint in all trials was change from baseline at week 24 in glycated hemoglobin ( HbA1c ). Other endpoints included changes in post-prandial plasma glucose ( PPG ), fasting plasma glucose ( FPG ) and weight.
Composite and safety endpoints were also analyzed.
A total of 501 patients aged greater than or equal to 65 years were included in this meta-analysis: 304 received Lixisenatide plus oral antidiabetics and 197 received placebo as add-on to oral antidiabetics.
Lixisenatide as an add-on to oral antidiabetics significantly reduced HbA1c, PPG, FPG and weight, with placebo-corrected treatment effects at week 24 of -0.54% ( p less than 0.0001 ), -126 mg/dL ( p less than 0.0001 ), -13 mg/dL ( p=0.0005 ) and -0.90 kg ( p=0.0021 ), respectively.
Patients receiving Lixisenatide plus oral antidiabetics were significantly more likely to achieve composite ( HbA1c levels less than 7%; HbA1c levels less than 7% and no symptomatic hypoglycemia; and HbA1c levels less than 7%, no weight gain and no symptomatic hypoglycemia ) and safety endpoints than those receiving placebo plus oral antidiabetics.
Symptomatic hypoglycemia was experienced by 8.55% and 3.55% of patients in the Lixisenatide plus oral antidiabetics and placebo plus oral antidiabetics groups, respectively ( p=0.0276 ), although no serious hypoglycemic episodes were reported.
In conclusion, Lixisenatide plus oral antidiabetics has improved glycemic control in older patients inadequately controlled on oral antidiabetics compared with placebo plus oral antidiabetics.
Lixisenatide is well tailored to the pathophysiology of type 2 diabetes mellitus in older patients. ( Xagena )
Hanefeld M et al, Adv Ther 2014;31:861-872