Dapagliflozin (7) – Forxiga®

• Clinical trials
  • In the double-blind, multicentre, randomised Phase III trial D1690C00017, dapagliflozin was compared with placebo in patients with type 2 diabetes mellitus aged between 10 and 24 years, in each case in addition to background therapy.

a) Insulin-naïve 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

• An additional benefit is not proven.
• Study D1690C00017 is not suitable for assessing the additional benefit of dapagliflozin, as the appropriate comparator therapy was not implemented.
• Furthermore, the pharmaceutical manufacturer treats all included patients as a single population and does not subdivide them into the two patient groups defined by the G-BA.
• Overall, the pharmaceutical manufacturer has not submitted any suitable studies for this patient population from which an additional benefit of dapagliflozin over the appropriate comparator therapy can be inferred.
• Overall assessment
  • On the basis of the study submitted, no conclusions can be drawn regarding the additional benefit of dapagliflozin compared with the appropriate comparator therapy.

b) Children and adolescents aged 10 to 17 with type 2 diabetes mellitus who have previously used insulin but have not achieved adequate blood glucose control with their current insulin regimen, in addition to diet and exercise

• The additional benefit is not proven.
• Study D1690C00017 is not suitable for assessing the additional benefit of dapagliflozin, as the appropriate comparator therapy was not implemented.
• Furthermore, the pharmaceutical manufacturer treats all included patients as a single population and does not subdivide them into the two patient groups defined by the G-BA.
• Overall, the pharmaceutical manufacturer has not submitted any suitable studies for this patient population from which an additional benefit of dapagliflozin over the appropriate comparator therapy can be inferred.
• Overall assessment
  • On the basis of the study submitted, no conclusions can be drawn regarding the additional benefit of dapagliflozin compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.