Once-weekly exenatide safe, effective for youths with type 2 diabetes
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Adolescents with type 2 diabetes were more likely to achieve HbA1c targets after 24 weeks of once-weekly exenatide compared with placebo, with trends observed toward decreased fasting plasma glucose and reduced body weight, data show.
The incidence and prevalence of type 2 diabetes among children and adolescents are increasing, particularly among minority racial and ethnic groups, Raafat Bishai, MD, senior director for research and development at AstraZeneca, said during a virtual presentation at the American Diabetes Association Scientific Sessions. The few available approved pharmacologic therapies — metformin, insulin and once-daily liraglutide 3 mg (Saxenda, Novo Nordisk) — have limitations. There are no once-weekly injectable therapies approved in the U.S. or Europe for youths with type 2 diabetes.
In a parallel-group, phase 3 study conducted across six countries, Bishai and colleagues analyzed data from 83 adolescents aged at least 10 years with type 2 diabetes, with or without insulin or sulfonylurea therapy, randomly assigned 5:2 to once-weekly exenatide 2 mg (Byetta, AstraZeneca; n = 59) or placebo (n = 24) for 24 weeks, followed by a 28-week, open-label extension phase. Dosing adjustments of exenatide during the trial were prohibited. Primary efficacy endpoint was change from baseline HbA1c at week 24; secondary efficacy endpoints were changes in fasting glucose, body weight and systolic blood pressure. Researchers also assessed the frequency of adverse events.
Within the cohort, 72 participants completed treatment (49 in the exenatide group and 23 in the placebo group).
At 24 weeks, once-weekly exenatide was superior to placebo in lowering HbA1c (least squares mean change, 0.36% vs. 0.49%, respectively), with a between-group difference of 0.85 percentage points (P = .012).
Researchers noted nonsignificant least squares mean differences from baseline to 24 weeks favoring exenatide for fasting glucose (21.6 mg/dL; 95% CI, 49 to 5.7), systolic BP (2.8 mm Hg; 95% CI, 8 to 2.4) and body weight (1.22 kg; 95% CI, 3.59 to 1.15).
Adverse events occurred in 61% and 73.9% in the exenatide and placebo groups, respectively; serious adverse events occurred in 3.4% and 4.3% of participants in exenatide and placebo groups, respectively. There were low rates of hypoglycemia, despite insulin use, and good gastrointestinal tolerability, even in the absence of exenatide titration when stating treatment, Bishai said.
“The first once-weekly GLP-1 receptor agonist exenatide demonstrated superiority in reducing HbA1c at 24 weeks vs. placebo in children and adolescents with type 2 diabetes not optimally controlled,” Bishai said during the presentation. “Exenatide was well tolerated, with a safety profile similar to other [GLP-1 receptor agonists]. It is a new treatment option for children and adolescents, conveniently administered once-weekly.”
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Tamborlane WV, et al. 91-LB. Presented at: American Diabetes Association Scientific Sessions; June 25-29, 2021 (virtual meeting).
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