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02-03-2023 | Empagliflozin | News

DINAMO: Empagliflozin shows promise for young people with type 2 diabetes

Author: Eleanor McDermid


medwireNews: Empagliflozin, but not linagliptin, provides “clinically relevant” improvements in glycemic control versus placebo in children and adolescents with type 2 diabetes, report the DINAMO investigators.

The 158 trial participants were aged 10–17 years (average approximately 14.5 years) and had been diagnosed with type 2 diabetes at least 8 weeks previously, with a glycated hemoglobin (HbA1c) level of 6.5% to 10.5% (48–91 mmol/mol) and a BMI in at least the 85th percentile for their age and sex.

They were randomly assigned to take linagliptin 5 mg, empagliflozin 10 mg, or placebo for 26 weeks in a double-blind, double-dummy trial design. At week 14, the 24 participants in the empagliflozin group who had not achieved HbA1c below 7.0% (53 mmol/mol) were rerandomized to take empagliflozin 10 or 25 mg for the remainder of the treatment period.

Baseline HbA1c averaged about 8% (64 mmol/mol) across the groups, and during treatment it rose by an adjusted average of 0.68% and 0.33% in participants taking placebo and linagliptin, respectively, and fell by 0.17% in the empagliflozin group.

This amounted to a placebo-corrected improvement averaging 0.84% in the empagliflozin group, which Lori Laffel (Harvard Medical School, Boston, Massachusetts, USA) and study co-authors say is clinically relevant as per the 0.5% threshold used in previous pediatric type 2 diabetes trials.

However, the placebo-corrected improvement of 0.34% achieved with linagliptin would be “considered as borderline, with uncertainties regarding the clinical relevance,” they write in The Lancet Diabetes & Endocrinology.

The researchers note that linagliptin and other dipeptidyl peptidase-4 inhibitors have demonstrated clinically relevant efficacy in adults, supporting the theory that “responses to antidiabetic medications in young people with type 2 diabetes differ from those in adults, which might reflect pathophysiologic differences in disease progression.”

Indeed, there was no significant improvement in bodyweight or blood pressure in either treatment group, contrasting with the benefits observed in adults taking empagliflozin.

The most frequent adverse event was hypoglycemia, which occurred in 19–23% of participants taking a study medication, compared with 9% of those in the placebo group. None of these events were classed as severe, however.

In a linked commentary, Sten Madsbad (Copenhagen University Hospital Hvidovre, Denmark) notes that obesity is the primary driver of type 2 diabetes in young people and that major weight loss, achieved with bariatric surgery, “is an effective treatment of type 2 diabetes.”

He therefore says that studies of high-dose semaglutide and tirzepatide, which both promote substantial weight loss in adults with type 2 diabetes, “are now urgently needed” in young people with the condition.

Madsbad adds that semaglutide 2.4 mg is already approved in the USA for children and adolescents with obesity but not diabetes, following the positive results of the STEP TEENS trial.

medwireNews is an independent medical news service provided by Springer Healthcare Ltd. © 2023 Springer Healthcare Ltd, part of the Springer Nature Group

Lancet Diabetes Endocrinol 2023; doi:10.1016/S2213-8587(22)00387-4
Lancet Diabetes Endocrinol 2023; doi:10.1016/S2213-8587(23)00030-X


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