Phase 3 trial finds oral empagliflozin provides safe glycemic control in children with type 2 diabetes (Linagliptin not helpful)

Medical Xpress / Joslin Diabetes Center / The Lancet Diabetes & Endocrinology ^ | Feb. 23, 2023 | Lori M Laffel et al

[ConservativeMind]

Researchers recently completed a phase 3 clinical trial that assessed the efficacy and safety of two different classes of oral agents for the treatment of type 2 diabetes in young people aged 10-17 years.

The findings represent a new treatment option for young people with type 2 diabetes and also underscore the differences in disease progression between young people and adults with type 2 diabetes.

"Type 2 diabetes was once called 'adult-onset diabetes,' but it is increasingly common among children," said Lori M. Laffel, MD, MPH.

Laffel and colleagues assessed the efficacy and safety of empagliflozin and linagliptin—two well-studied oral agents with demonstrated safety and efficacy in adults with type 2 diabetes.

Participants were randomly assigned to receive one of three regimens; empagliflozin, linagliptin and placebo once daily for 26 weeks.

In the empagliflozin group, researchers determined that participants' hemoglobin A1C (HbA1C) levels, a measure of average blood sugar levels over the past two to three months, decreased by week four and remained below that of the placebo group at week 26, demonstrating an improvement in diabetes control with an adjusted mean difference in HbA1c of 0.84% favoring empagliflozin compared with placebo.

In the linagliptin group, the scientists found an initial decrease in HbA1C at week four, followed by an increase toward baseline values at week 26, which was similar to that seen in the placebo group. Similarly, when the researchers looked at participants' fasting plasma glucose, they saw larger effects in the empagliflozin group versus the placebo group. The safety profiles of both empagliflozin and linagliptin matched that seen in studies of adults with type 2 diabetes.

"Our findings show that an empagliflozin dosing regimen provides a clinically relevant and statistically significant reduction in HbA1C in young people with type 2 diabetes, whereas linagliptin did not," said Laffel.

[ConservativeMind]

Another option for young diabetics who can’t correct their eating and exercise situation.

[ConservativeMind]

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