German pharmaceutical MNC Boehringer Ingelheim and US pharma giant Eli Lilly and Company announced on December 7, 2022, that the duo’s anti-diabetic drug empagliflozin, marketed as Jardinace, has shown a significant reduction in blood sugar levels among youngsters aged between 10 to 17 years during a phase-3 trial.

In  a joint statement press communiqué, the companies informed that the clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c with empagliflozin compared with a placebo for children and adolescents aged 10-17 years living with type 2 diabetes.

The trial included youth aged 10-17 years with type 2 diabetes and HbA1c ≥6.5% and ≤10.5%, where the participants were randomly assigned treatment with empagliflozin (10 or 25 mg) (n=52), linagliptin (5 mg) (n=53) or placebo (n=53) once daily.

All participants were treated with diet and exercise plus, metformin and or insulin as and when required, the statement added.

The findings of the trial were presented at the International Diabetes Federation’s World Diabetes congress 2022 and will shortly be submitted to peer-reviewed journals, the companies further informed.

“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it is important to recognise and treat diabetes early in its course,” Dr Lori Laffel, the principal investigator of the trial and Professor of Paediatrics at Harvard Medical School said.

“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,” he added.

Dr Laffel further pointed out that the trial findings are important, as there is a need for more treatment options, especially oral agents, to manage type 2 diabetes in young people because metformin is the only globally available oral treatment for youth currently.

Commenting on the findings, Dr Lykke Hinsch Gylvin, the Chief Medical Officer at Boehringer Ingelheim, said, “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.”

“The clinically meaningful benefit and consistent safety profile demonstrated with empagliflozin in the DINAMO trial is an encouraging outcome for the vulnerable population of children and adolescents.”

“The rise in the prevalence of type 2 diabetes in the paediatric population highlights a clear unmet need,” Dr Jeff Emmick, Vice President, Product Development at Eli Lilly & Company, said.