Dapagliflozin (2) – Forxiga®

b) In combination with another blood-glucose-lowering medicinal product (other than insulin; in this case, metformin), if this medicinal product does not adequately control blood glucose levels in conjunction with diet and exercise

• For patients being treated with dapagliflozin in combination with another blood glucose-lowering medicinal product (other than insulin; in this case, metformin), where this medicinal product, together with diet and exercise, does not adequately control blood glucose, the additional benefit is not proven.
• Conclusion
  • Overall, the G-BA concludes that the studies submitted for the benefit assessment – DapaZu and D1690C00004 – are not suitable for establishing an additional benefit for dapagliflozin plus metformin compared with the appropriate comparator therapy.
  • In the DapaZu study, the titration regimen for glimepiride used in the control arm does not correspond to an adequate, patient-specific titration in accordance with the recommendations of the guidelines and the information provided in the summary of product characteristics (SmPC).
  • Similarly, the results of the D1690C00004 study cannot be interpreted due to methodological shortcomings.
  • Taken together, the results of the two studies are highly biased due to the study design, and a valid interpretation of the endpoints is not possible. For this reason, the G-BA concludes that for patients treated with dapagliflozin in combination with another blood glucose-lowering medicinal product (other than insulin, in this case metformin) – where this does not adequately control blood glucose levels in conjunction with diet and exercise – additional benefit is not proven compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.