Source / information
Published by:
Source:
Tamborlan WV et al. 91-LB. Presented at: Scientific Sessions of the American Diabetes Association; 25-29 June 2021 (virtual meeting).
Disclosure:
Bishai reports that he is an employee of AstraZeneca. Please refer to the poster for all relevant financial information from the other authors.
ADD SUBJECT TO EMAIL ALERTS
Receive an email when new articles are published on
Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe
We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.
Back to Healio
Adolescents with type 2 diabetes were more likely to achieve HbA1c targets after 24 weeks of once-weekly administration of exenatide compared to placebo, with trends toward decreased fasting plasma glucose and decreased body weight, the data show.
The incidence and prevalence of type 2 diabetes in children and adolescents is increasing, especially among ethnic minorities, Raafat Bishai, MD, Senior Director of Research and Development at AstraZeneca said during a virtual presentation at the American Diabetes Association’s Scientific Sessions. The few approved pharmacological therapies available – metformin, insulin, and liraglutide 3 mg once daily (Saxenda, Novo Nordisk) – have limitations. In the US or Europe, once-weekly injectable therapies are not approved for adolescents with type 2 diabetes.
Source: Shutterstock
In a parallel group phase 3 study conducted in six countries, Bishai and colleagues randomly analyzed data from 83 adolescents aged 10 years or older with type 2 diabetes, with or without insulin or sulfonylurea therapy 5 : 2 with exenatide 2 mg once weekly (Byetta, AstraZeneca; n = 59) or placebo (n = 24) for 24 weeks, followed by a 28-week open-label extension phase. Dose adjustments of exenatide during the study were prohibited. The primary efficacy endpoint was change in baseline HbA1c at week 24; secondary efficacy endpoints were changes in fasting glucose, body weight, and systolic blood pressure. The researchers also rated the frequency of adverse events.
Within the cohort, 72 participants completed treatment (49 in the exenatide group and 23 in the placebo group).
After 24 weeks, exenatide once-weekly was superior to placebo for lowering HbA1c (smallest root mean square change, 0.36% and 0.49%, respectively), with an intergroup difference of 0.85 percentage points (P = 0.012).
The researchers found nonsignificant least-squares differences between baseline and 24 weeks using exenatide for fasting glucose (21.6 mg / dL; 95% CI 49-5.7), systolic blood pressure (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 the exenatide and placebo groups, respectively. There were low rates of hypoglycaemia and good gastrointestinal tolerance despite insulin use, even when exenatide was not titrated at baseline, Bishai said.
“The first once-weekly GLP-1 receptor agonist exenatide demonstrated superiority in lowering HbA1c after 24 weeks compared to placebo in children and adolescents with sub-optimal control of type 2 diabetes,” said Bishai during the presentation. “Exenatide was well tolerated with a similar safety profile to others [GLP-1 receptor agonists]. It is a new treatment option for children and adolescents that is conveniently administered once a week. “
ADD SUBJECT TO EMAIL ALERTS
Receive an email when new articles are published on
Please enter your email address to receive an email when new articles are published on . “data-action =” subscribe “> subscribe
We could not process your request. Please try again later. If this problem persists, please contact customerservice@slackinc.com.
Back to Healio
