Daily liraglutide, in addition to metformin and insulin, reduces hemoglobin A1c (HbA1c) and improves glycemic control in children and adolescents with type 2 diabetes (T2D), according to study results presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD), held September 16 to 20, 2019, in Barcelona, Spain.
Children and adolescents (mean age, 14.6 years) were randomly assigned to receive either liraglutide up to 1.8 mg/d (n=66) or placebo (n=68). Treatment consisted of a 26-week double-blind period and then a 26-week open-label extension period. Participants had to have a body mass index >85th percentile for the general age- and sex-matched population and HbA1c ≥7.0% and ≤11% if treated by diet and exercise only, or HbA1c ≥6.5% and ≤11% if they received metformin and/or basal insulin.
Researchers assessed the change in HbA1c from baseline to 26 weeks. Changes in fasting plasma glucose and several safety outcomes were also examined.
In the liraglutide group, treatment was associated with a reduction in HbA1c from 7.87% at baseline to 7.13% at 26 weeks (estimated treatment difference vs placebo, -1.06%; 95% CI, ‐1.65% to -0.46%; P <.001). At 52 weeks, treatment with liraglutide was still associated with reductions in HbA1c, whereas placebo was associated with an increase in HbA1c (estimated treatment difference, -1.30%; 95% CI, ‐1.89% to -0.70%; P <.001). Decreases in fasting plasma glucose were also observed at 26 weeks and 52 weeks with liraglutide (-19.82 and -18.02 mg/dL, respectively), whereas increases in fasting plasma glucose were observed with placebo (+14.41 and +14.41 mg/dL, respectively).
A similar percentage of patients in the liraglutide and placebo groups reported an adverse event (84.8% and 80.9%, respectively); however, the rate of gastrointestinal-related adverse events was higher with liraglutide (33.3% vs 13.2%).
According to the researchers, a limitation of the study was its long recruitment period, which was primarily because of issues with recruiting in this hard-to-reach patient population.
“[Liraglutide] probably needs a health-technology assessment and a cost-benefit analysis and health-economic analysis,” said study presenter Timothy Barrett, MD, when asked about his findings during a session at EASD 2019. “I think we will need some follow-up studies to see what the long-term effects are and if there are complications, and I think we need population-based, real-life data of patients who started on this treatment.”
Disclosure: This clinical trial was supported by Novo Nordisk. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.
Barrett T, Tamborlane WV, Fainberg U, et al. Efficacy and safety of liraglutide vs placebo in children and adolescents with type 2 diabetes: the ellipse randomised trial results. Presented at: European Association for the Study of Diabetes 55th Annual Meeting; September 16-20, 2019; Barcelona, Spain. Abstract 84.