Boehringer Ingelheim and Eli Lilly have announced positive results from a phase 3 trial for Jardiance in reducing blood sugar levels in children with type 2 diabetes.
Empagliflozin (Jardiance;Boehringer Ingelheim and Eli Lilly) has shown positive results in a phase 3 trial for reducing blood sugar levels in pediatric patients with type 2 diabetes.
The phase 3 DINAMO (DIabetes study of liNAgliptin and eMpagliflozin in children and adOlescents) trial had a primary endpoint of significantly reduced HbA1c, which is used as a marker of blood sugar levels. Compared with a placebo, empagliflozin saw an HbA1c reduction of 0.84% in pediatric patients aged 10 to 17 years with type 2 diabetes at week 26.
Participants in the trial had HBA1c levels between 6.5% and 10.5% and were randomly assigned treatment with empagliflozin 10 mg or 25 mg, linagliptin (Tradjenta; Boehringer Ingelheim) 5 mg, or placebo. Diet and increased exercise were also used as treatment when necessary, along with metformin and insulin.
Safety information in pediatric patients was constant with data seen in adults, establishing a safety profile for empagliflozin and linagliptin. Reduced fasting plasma glucose was also seen at week 26 in patients who had taken empagliflozin, making the secondary endpoint of the study successful.
Compared to the efficacy of empagliflozin, linagliptin saw reduced results. HbA1c reduction was not significant in linagliptin when compared to placebo.
Lori Laffel, MD, lead investigator of the DINAMO study, said that many individuals with type 2 diabetes experience a high risk for complications throughout their lives, making early recognition and treatment vital. Empagliflozin can be another oral medication for youth, as metformin is currently the only oral treatment approved for use in children worldwide.
Empagliflozin is currently approved for reducing cardiovascular disease risk and blood sugar in adults with type 2 diabetes. It should not be used in individuals with type 1 diabetes or severe kidney problems. Adverse events include ketoacidosis, nausea, vomiting, trouble breathing, tiredness, dehydration, abdominal pain, urinary tract infection, and low blood sugar.
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. Lilly Investors. December 7, 2022. Accessed December 7, 2022. https://investor.lilly.com/news-releases/news-release-details/phase-iii-trial-demonstrated-jardiancer-first-sglt2-inhibitor