The objective of a study was to evaluate the pharmacokinetics, efficacy and safety of Lixisenatide ( subcutaneous injection ) ( Lyxumia ) in elderly ( greater than or equal to 65 years old ) and very elderly ( greater than or equal to 75 years old ) patients with type 2 diabetes mellitus.
A phase I, single-centre, open-label study to evaluate the safety and pharmacokinetics of a single Lixisenatide 20 mcg dose was conducted, and a pooled analysis of six randomized, placebo-controlled, phase III studies ( 12-month or 24-month duration ) that evaluated glycaemic parameters and safety in patients receiving Lixisenatide 20 mcg once daily or placebo.
The pharmacokinetics study included 36 healthy subjects, including 18 elderly healthy subjects ( greater than or equal to 65 years old ) and 18 matched young healthy subjects ( 18-45 years old ).
The pooled analysis included 3188 patients, including 2565 patients less than 65 years old and 623 patients greater than or equal to 65 years old ( including 79 patients greater than or equal to 75 years old ).
Mean exposure with Lixisenatide 20 mcg was approximately 30% higher in elderly than in young subjects, and the terminal half-life was prolonged by approximately 1.6 times.
Maximum concentration ( Cmax ) and time to Cmax ( tmax ) were comparable in both groups.
Equal numbers of elderly and young subjects reported treatment-emergent adverse events, the majority of which were gastrointestinal disorders.
In the pooled analysis, Lixisenatide 20 mcg once daily provided significant reductions in HbA1c versus placebo for all age groups.
There was a similar incidence of treatment-emergent adverse events across all age groups ( range: 69-73% ). The incidence of symptomatic hypoglycaemia was generally comparable between Lixisenatide-treated and placebo-treated patients.
In conclusion, these data suggest that Lixisenatide is effective and well tolerated in elderly and very elderly patients with type 2 diabetes mellitus. ( Xagena )
Raccah D et al, Diabetes Metab Res Rev 2014; Epub ahead of print