Liraglutide add-on lowers HbA1c in pediatric type 2 diabetes
Adding a regimen of 1.8 mg per day of liraglutide to metformin therapy can better reduce HbA1c levels in children with type 2 diabetes compared with metformin alone, according to findings published in The New England Journal of Medicine and presented at the Pediatric Academic Societies’ annual meeting.
“Having a GLP-1 agonist available for treatment of pediatric [type 2 diabetes] is transformational,” William V. Tamborlane, MD, professor and chief of pediatric endocrinology at Yale School of Medicine in New Haven, Connecticut, told Endocrine Today. “Currently, insulin is the only approved rescue drug for kids who fail metformin monotherapy but insulin added to metformin often fails to rescue youth with [type 2 diabetes]. We now have a second option when metformin monotherapy fails.”
These findings are a result of the ELLIPSE trial in which Tamborlane and colleagues examined data from 134 children aged 10 to 17 years (mean age, 14.6 years; 61.9% girls) with type 2 diabetes, a BMI in at least the 85th percentile and HbA1c levels of 7% to 11% who participated in a double-blind, randomized trial in which they were given a regimen of 1.8 g liraglutide (Victoza, Novo Nordisk) per day in addition to metformin or metformin therapy alone. Participants were randomly assigned to one of the two treatment plans for 26 weeks after which a 26-week open-label period was conducted.
The researchers observed a 0.64 percentage point decline in HbA1c in the liraglutide group compared with a 0.42 percentage point increase in the metformin-alone group (P < .001) during the first 26 weeks, while noting that the gap between the two groups’ HbA1c levels rose 1.3 percentage points (95% CI, 0.7-1.89) after the open-label period. More participants who received liraglutide lowered their HbA1c measures below the 7% mark compared with those in the metformin-alone group (63.7% vs. 36.5%; P < .001). Fifty-six participants who received liraglutide had adverse events, primarily of a gastrointestinal nature, compared with 55 reported adverse events in the metformin group. The researchers also noted that there was no statistical difference in BMI z score between the two groups after treatment.
According to a press release from Novo Nordisk, these results will now be reviewed by the FDA and European Medicines Agency. – by Phil Neuffer
Disclosures: Tamborlane reports that Novo Nordisk is funding an investigator-initiated studies in type 1 diabetes for which he is an investigator. Please see the study for all other authors’ relevant financial disclosures.