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
Jardiance® (empagliflozin) is the first SGLT2 inhibitor to demonstrate a statistically significant reduction in the primary outcome of HbA1c (a marker of average blood sugar) in participants aged 10-17 living with type 2 diabetes compared to placebo
Safety data in this vulnerable population was similar to that in adults with type 2 diabetes, confirming the well-established safety profile of empagliflozin
INGELHEIM, GERMANY & INDIANAPOLIS--(Business Wire / Korea Newswire) December 08, 2022 -- The DINAMO Phase III clinical trial met its primary endpoint by demonstrating a statistically significant reduction in HbA1c (a marker of average blood sugar) with empagliflozin compared with placebo for children and adolescents aged 10-17 years living with type 2 diabetes. When empagliflozin was added to other baseline treatments (diet, exercise, metformin and/or insulin) HbA1c was reduced by 0.84% compared with placebo at week 26 (95% CI -1.50 to -0.19; P=0.012).1 The results were presented today at the International Diabetes Federation (IDF) World Diabetes congress 2022, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced.
The DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial included youth aged 10-17 years with type 2 diabetes and HbA1c ≥6.5% and ≤10.5%. 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, when appropriate, metformin and/or insulin.
The overall safety data was generally consistent with previous findings in adults with type 2 diabetes, confirming the well-established safety profile of both Jardiance® (empagliflozin) and Trajenta® (linagliptin).
“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, M.D., 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. “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.”
A secondary endpoint from the trial showed that at week 26, empagliflozin reduced fasting plasma glucose (-35.2 mg/dL; P=0.0035).
“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 rise of risk factors such as obesity,” said Lykke Hinsch Gylvin, M.D., Chief Medical Officer at Boehringer Ingelheim. “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 pediatric population highlights a clear unmet need,” said Jeff Emmick, M.D., Ph.D., Vice President, Product Development, Eli Lilly & Company. “Having overcome the challenges in recruitment and design that pediatric trials tend to face, the outcomes of DINAMO represent another positive step forward in Boehringer Ingelheim and Lilly’s commitment to improve the lives of people living with cardio-renal and metabolic conditions such as type 2 diabetes.”
Reduction in HbA1c in participants treated with linagliptin was not statistically significant when compared with placebo. A numerical reduction of 0.34% (P=0.2935) was observed.
The findings have been submitted for publication in a peer-reviewed journal.
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