Tirzepatid (2) – Mounjaro®

• Clinical trials
  • This is a randomised, double-blind, placebo-controlled Phase III trial.

Children and adolescents aged 10 to < 18 years with type 2 diabetes mellitus who have not achieved adequate blood glucose control with their current medication, in addition to diet and exercise

• The additional benefit is not proven.
• The pharmaceutical manufacturer does not present any suitable study in its dossier for the assessment of the additional benefit of tirzepatide compared with the appropriate comparator therapy.
• In this study, prior treatment with metformin and/or basal insulin was continued in both arms and could only be escalated in the event of hyperglycaemia.
• The continuation of inadequate antidiabetic therapy in this context does not constitute the implementation of the specified appropriate comparator therapy.
• In accordance with the pharmaceutical manufacturer’s approach as set out in the dossier, this study is not taken into account for the present benefit assessment due to the lack of comparison with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.