Empagliflozin (6) – Jardiance®

• Clinical trials
  • As part of the benefit assessment, the pharmaceutical manufacturer presents the results of the double-blind, multicentre DINAMO trial, in which empagliflozin was compared with linagliptin and placebo in patients with type 2 diabetes mellitus aged 10 to 17 years inclusive, in each case in addition to diet, exercise and a stable dose of metformin, insulin or metformin plus insulin.

Children and adolescents aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their current drug therapy consisting of at least one blood glucose-lowering medicinal product in addition to diet and exercise

• The additional benefit is not proven.
• Overall, there are therefore no suitable data available to assess the additional benefit of empagliflozin compared with the appropriate comparator therapy in children and adolescents aged 10 to 17 years with uncontrolled type 2 diabetes mellitus. An additional benefit of empagliflozin compared with the appropriate comparator therapy is not proven.
• morbidity
  • The primary endpoint of the study was the change in HbA1c levels from the start of the study to week 26.
  • Further endpoints were assessed in the categories of morbidity and side effects.
• Overall review
  • Overall, for children and adolescents aged 10 to 17 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their current medication regimen—consisting of at least one blood glucose-lowering medicinal product in addition to diet and exercise— The additional benefit of empagliflozin compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.