STUDY DESIGN

Compared to their adult counterparts, children and adolescents with type 2 diabetes mellitus (T2DM) experience an accelerated deterioration in beta-cell function and development of insulin resistance, thereby elevating their risk of early-onset complications. Currently, treatment options for young-onset T2DM are limited to injections and metformin, the only globally approved oral agent.¹ To assess the efficacy and safety of empagliflozin and linagliptin in young-onset T2DM, the DINAMO trial, a randomized, double-blind, placebo-controlled study, was conducted.¹ A subsequent post-hoc analysis was commenced to evaluate the effects of background insulin therapy on the treatment outcomes of empagliflozin and linagliptin.

The DINAMO trial enrolled a total of 158 children and adolescents with T2DM, upon which 43.3% of patients were prescribed insulin therapy. The study population (n=158) was randomized to placebo, linagliptin 5mg, or empagliflozin 10mg.¹ At week 12, patients who failed to reach a hemoglobin A1c (HbA1c) level of <7% in the empagliflozin 10mg arm were further randomized into either continuing their treatment or receiving empagliflozin 25mg instead.¹ After the primary endpoint analysis at week 26, patients from the placebo arm were also randomized into receiving linagliptin 5mg, empagliflozin 10mg, or empagliflozin 25mg.¹

The primary endpoints of this post-hoc analysis were the adjusted mean changes in HbA1c and fasting plasma glucose (FPG) levels from baseline to week 26 and week 52.¹

“These results support the use of empagliflozin as a new oral treatment option in young people with T2DM, delaying the need for insulin therapy”  

^{Dr. Igor Tartakovsky 
Boehringer Ingelheim International GmbH,
Ingelheim, Germany}