Empagliflozin achieved a significant reduction in hemoglobin A1c (HbA1c) in patients 10 to less than 18 years of age with type 2 diabetes, according to phase 3 trial results from the International Diabetes Federation (IDF) World Diabetes congress 2022.
The double-blind, randomized, placebo-controlled, parallel group DINAMO trial (ClinicalTrials.gov Identifier: NCT03429543) evaluated the efficacy and safety of empagliflozin and linagliptin in 175 patients 10 to less than 18 years of age with type 2 diabetes. The trial included patients with HbA1c of 6.5% to 10.5% at screening who are currently taking metformin, insulin or both, or who are treatment naïve or not on active treatment after metformin withdrawal.
Patients were randomly assigned 1:1:1 to receive empagliflozin (10mg or 25mg) (n=52), linagliptin (5mg) (n=53), or placebo (n=53) once daily for 26 weeks. All patients were treated with diet and exercise plus, when appropriate, metformin and/or insulin. The primary endpoint was the change from baseline in HbA1c at week 26.
Results showed that empagliflozin achieved a statistically significant reduction in HbA1c of 0.84% at week 26 compared with placebo (95% CI, -1.50, -0.19; P =.012). Moreover, empagliflozin significantly reduced the fasting plasma glucose (secondary endpoint) at week 26 (-35.2mg/dL; P =.0035). Treatment with linagliptin did not achieve statistical significance in HbA1c reduction when compared with placebo.
The overall safety profile of empagliflozin was generally consistent with previous findings in adults with type 2 diabetes. Trial findings have been submitted for publication in a peer-reviewed journal.
“Today’s results from the DINAMO global clinical trial demonstrated that the SGLT2 inhibitor empagliflozin compared with placebo significantly improved overall blood sugar control in children and adolescents with type 2 diabetes. These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin is the only globally available oral treatment for youth,” said Lori Laffel, MD, Principal Investigator of the DINAMO study and Chief of the Pediatric, Adolescent, and Young Adult Section at the Joslin Diabetes Center and Professor of Pediatrics at Harvard Medical School.
Empagliflozin is currently marketed under the trade name Jardiance and is approved as adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Phase III trial demonstrated Jardiance® is the first SGLT2 inhibitor to show statistically significant reduction in blood sugar levels in children and adolescents with type 2 diabetes. News release. Boehringer Ingelheim and Eli Lilly and Company. Accessed December 7, 2022. https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/diabetes/new-positive-data-phase-iii-type-2-diabetes-trial.