Once-daily liraglutide reduces BMI, HbA1c for adolescents with type 1 diabetes and obesity
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Once-daily liraglutide 3 mg as an adjunctive to lifestyle intervention is associated with a reduction in body weight and HbA1c for adolescents with type 1 diabetes and obesity, according to a speaker.
As Healio previously reported, the FDA approved liraglutide 3 mg (Saxenda, Novo Nordisk) for the treatment of obesity among adolescents aged 12 to 17 years and a body weight of at least 60 kg or a BMI corresponding to 30 kg/m2 for adults. In new findings presented at the International Conference on Advanced Technologies & Treatments for Diabetes, researchers observed a reduction in BMI standard deviation score as well as in HbA1c and fasting glucose among a small group of adolescents with obesity and type 1 diabetes.
“We have different [pharmacotherapy] options in adults in comparison to children,” Nancy Samir Elbarbary, MBBCh, MSc, MD, PhD, professor of pediatrics in the pediatric diabetes unit and consultant of pediatric diabetes at Ain Shams University in Cairo, said during a presentation. “We see limited options [for adolescents] with orlistat, which is FDA-approved since the age of 12, and phentermine, which is FDA-approved since the age of 16. The European Medicines Agency does not approve any of the pharmacotherapies in children. This is the same as when we’re looking at bariatric surgery. ... Those options are limited in adolescents and are performed infrequently. That’s why we need to look at a pharmacotherapy treatment option that can be used in adolescents with type 1 diabetes.”
Elbarbary and colleagues conducted a single-arm trial enrolling 32 adolescents aged 12 to 17 years with type 1 diabetes and obesity who had an inadequate response to lifestyle therapy alone and had less than a 5 kg self-reported weight change for 90 or more days before recruitment (84.3% girls; mean age, 15.6 years). Participants received 0.6 mg subcutaneous liraglutide at 1 week, with the dose increasing by 0.6 mg each week until reaching the full dose of 3 mg at 5 weeks. The study duration was 26 weeks. Researchers collected a detailed medical history at baseline. Clinical examinations were conducted at baseline and 26 weeks. Blood samples were collected at both timepoints.
There were 21 adolescents who completed the study with 11 discontinuing treatment prior to 26 weeks. Of completers, 53.1% lost at least 5% of their baseline BMI, and 31.2% lost at least 10% at 26 weeks. The cohort had a mean reduction in BMI standard deviation score of 0.26 at 26 weeks (P = .001).
Mean HbA1c dropped from 8.5% at baseline to 7.4% at 26 weeks (P = .01). The cohort also had reductions in fasting glucose and postprandial glucose increment from baseline to 26 weeks. The number of basal insulin units needed decreased from 31.6 at baseline to 22.4 at 26 weeks (P < .001), and total bolus insulin units decreased from 24.8 at baseline to 16.5 at 26 weeks (P = .02). No changes were observed for blood pressure and fasting lipid parameters.
Most adverse events were gastrointestinal in nature, with nausea and vomiting the most common. No serious adverse events were reported.
“Daily liraglutide as an adjuvant therapy, and lifestyle [intervention] is effective in producing significant body weight reduction in Egyptian obese adolescents with type 1 [diabetes] with tolerable minimal side effects,” Elbarbary said. “This was associated with improvement of glycemic control despite lower doses of both basal and bolus insulin and without increase in hypoglycemic events.”