Results of a phase 3 clinical trial represent another avenue of treatment for children and adolescents living with type 2 diabetes.
Results of the DINAMO clinical trial (NCT03429543) have demonstrated the effectiveness of empagliflozin (Jardiance) in children and adolescents with type 2 diabetes (T2D), according to a news release from Eli Lilly. Specifically, the data showed a statistically significant reduction in levels of hemoglobin A1c (HbA1c).
The phase 3 trial results make empagliflozin the first sodium-glucose cotransporter-2 (SGLT2) inhibitor to show statistically significant reduction in blood sugar levels in pediatric T2D, according to the news release.1Results from the DINAMO (Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents) clinical trial were presented at the International Diabetes Federation World Diabetes Congress 2022, held in Lisbon, Portugal, December 5-8, 2022.
When added to other baseline treatments, such as diet, exercise, metformin, and/or insulin, empagliflozin therapy was associated with a reduction in HbA1c of 0.84% in children and adolescents between aged 10 and 17 years with T2D (HbA1c ≥6.5% and ≤10.5%) compared with placebo at week 26.
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications so it’s important to recognize and treat diabetes early in its course,” 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.
These study 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,” Laffel added.
Participants were randomly assigned to receive treatment with 10 mg or 25 mg empagliflozin, 5 mg linagliptin (Tradjenta), or placebo once daily (n=52, 53, and 53, respectively). All participants were treated with diet and exercise plusmetformin and/or insulin where appropriate.
A secondary endpoint from the trial showed that at week 26, empagliflozin therapy reduced fasting plasma glucose (–35.2 mg/dL; P =.0035).
However, the reduction in HbA1c in participants treated with linagliptin was not statistically significant compared with placebo, the researchers found(–34%; P =.2935).
Overall safety data were generally consistent with previous findings in adults with T2D, “confirming the well-established safety profile of both [empagliflozin] and [linagliptin],” the news release noted.1
“With more than 41,000 new cases worldwide annually, type 2 diabetes in today’s young people is a global public health issue, especially in light of the rise of risk factors such as obesity,” said Lykke Hinsch Gylvin, MD, chief medical officer at Boehringer Ingelheim. “The clinically meaningful benefit and consistent safety profile demonstrated with Jardiance in the DINAMO trial is an encouraging outcome for the vulnerable population of children and adolescents.”
Findings of the DINAMO study have been submitted for publication in a peer-reviewed journal.
1. 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. Eli Lilly and Company. December 7, 2022. Accessed January 10, 2023. https://investor.lilly.com/news-releases/news-release-details/phase-iii-trial-demonstrated-jardiancer-first-sglt2-inhibitor