Tamborlane WV, et al. – In this study, researchers determined if liraglutide added to metformin (with or without basal insulin treatment) is safe and effective in young people with type 2 diabetes. In children and adolescents with type 2 diabetes, liraglutide was found to be effective in improving glycemic control over 52 weeks at a dose of up to 1.8 mg daily (added to metformin, with or without basal insulin). This effectiveness, however, came at the cost of higher frequency of adverse gastrointestinal events.

Methods

• Study participants aged 10 years to < 17 years were randomized to receive subcutaneous liraglutide (up to 1.8 mg per day) or placebo for a 26-week double-blind period in a 1:1 ratio, followed by a 26-week open-label extension period.
• Inclusion criteria were a body-mass index higher than the 85th percentile and a glycated hemoglobin level between 7.0% and 11.0% if the patients were being treated with diet and exercise alone or between 6.5% and 11.0% if metformin (with or without insulin) was used.
• During the trial, all the patients received metformin.
• The primary endpoint after 26 weeks was the baseline change in the level of glycated hemoglobin.
• The change in fasting plasma glucose level was the secondary end point.
• Throughout the course of the trial, safety was assessed.

Results

• Of 135 randomized patients, 134 received ≥ 1 liraglutide dose (66 patients) or placebo dose (68 patients).
• Both groups had similar demographic characteristics (mean age: 14.6 years).
• The mean glycated hemoglobin level decreased by 0.64 percentage points with liraglutide at the 26-week primary efficacy endpoint analysis, and increased by 0.42 percentage points with placebo for an estimated treatment difference of −1.06 percentage points (P < 0.001); the difference increased by 52 weeks to −1.30 percentage points.
• The level of fasting plasma glucose in the liraglutide group declined at both points of time but increased in the placebo group.
• The number of patients reporting adverse events in both groups was similar (56 [84.8%] with liraglutide and 55 [80.9%] with placebo), but the overall rates of adverse events and adverse gastrointestinal events with liraglutide were higher.