This study randomised 680 patients to lixisenatide morning (n =255), lixisenatide evening (n=255), placebo morning (n=85), or placebo evening (n=85) injections. The primary end point was the absolute change in HbA1c from baseline to week 24 in the morning injection treatment arm and was assessed in the modified intent to- treat (mITT) population. The main secondary end point was HbA1c reduction for the evening injection arm.
The following findings were reported:
• Lixisenatide morning injection reduced mean HbA1c versus placebo (mean change −0.9% [9.8 mmol/mol] lixisenatide vs. −0.4% [4.4 mmol/mol] combined placebo groups, p< 0.0001).
• HbA1c was reduced by lixisenatide evening injection (mean change –0.8% [8.7 mmol/mol] vs. –0.4% [4.4 mmol/mol]; p<0.0001).
• Mean body weight decreased to a similar extent in all groups.
• Rates of adverse events were 69.4% in both lixisenatide groups and 60.0% in the placebo group.
• Rates for nausea and vomiting were 22.7 and 9.4% for lixisenatide morning and 21.2 and 13.3% for lixisenatide evening versus 7.6 and 2.9% for placebo, respectively.
• Symptomatic hypoglycaemia occurred in 6, 13, and 1 patient for lixisenatide morning, evening, and placebo, respectively, with no severe episodes.
In February 2013, the European Commission granted Marketing Authorisation for lixisenatide (Lyxumia®) for the treatment of adults with type 2 diabetes mellitus, to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycaemic control. The approval was based on results from the GetGoal clinical programme, which included 11 clinical trials involving more than 5000 patients with type 2 diabetes.
NICE recently published a new medicines evidence summary on lixisenatide – please click on link for information.