NEWS & PERSPECTIVE
Empagliflozin achieves clinically meaningful reduction in HbA1c among young T2D patients
A recent phase 3 clinical trial demonstrated that empagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, achieved a statistically significant reduction in glycated hemoglobin (HbA1c) when compared with placebo among children aged 10-17 years with type 2 diabetes (T2D) who had previously been treated with metformin or insulin, offering pediatric patients a potential new treatment option to bring the blood sugar under control.
The incidence of T2D in children and adolescents worldwide has been increasing over the past 2 decades, coinciding with the rise in the prevalence of childhood obesity.
DINAMO was a double-blinded, randomized, placebo-controlled, phase 3 study that evaluated the safety and efficacy of empagliflozin vs. linagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor works by reducing blood sugar by increasing insulin levels, or placebo in children and adolescents aged 10-17 years with T2D.
The study results showed that in the group receiving empagliflozin along with other baseline treatments, such as diet, exercise, metformin and/or insulin, HbA1c was significantly reduced by 0.84% compared with placebo at week 26 (95% CI: -1.50 to -0.19; p=0.012), while linagliptin achieved a numerical but non-significant reduction in Hb1Ac of 0.34% (95% CI: -0.99 to 0.30; p=0.29).1 Empagliflozin was well tolerated by pediatric T2D patients, with a safety profile consistent with previous safety findings among adult patients.1 The rates of serious adverse events (AEs) were comparable between the empagliflozin arm (2%) and the placebo arm (4%).1 Hypoglycemia was the most reported AE among patients with active anti-diabetic treatments.1 No episode of severe hypoglycemia was reported.1
In summary, the favorable safety findings and high efficacy of empagliflozin demonstrated in the DINAMO trial showed great promise for the drug as the first SGLT2 inhibitor to be used for the treatment of children and adolescents with T2D.
Empagliflozin as an efficacious novel oral option for youth-onset type 2 diabetes patients without insulin therapy: Post-hoc analysis of the DINAMO trial
STUDY DESIGN Compared to their adult counterparts, children and adolescents with type 2 diabetes mellitus (T2DM) experience an accelerated deterioration in beta-cell function and development of insulin resistance, thereby elevating their risk of early-onset complications. Currently, treatment optio
Beyond diabetes: FDA now approves dapagliflozin for the treatment of chronic kidney disease
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