Dapagliflozin (1) – Forxiga®

a) Monotherapy in patients in whom diet and exercise do not adequately control blood glucose levels and in whom the use of metformin is considered unsuitable due to intolerance

• For patients treated with dapagliflozin monotherapy, in whom diet and exercise do not adequately control blood glucose levels and in whom the use of metformin is considered unsuitable due to intolerance, the additional benefit is not proven.
• In its summary assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that there is no additional benefit of dapagliflozin over the appropriate comparator therapy – sulphonylureas (glibenclamide, glimepiride)—has been established.

b) Add-on combination therapy with metformin, where metformin, together with diet and exercise, does not adequately control blood glucose

• Having assessed the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that no additional benefit of dapagliflozin over the appropriate comparator therapy – sulphonylureas (glibenclamide, glimepiride) combined with metformin.
• morbidity
  • The D1690C00004 study investigated adult patients with type 2 diabetes mellitus in whom adequate blood glucose control had not been achieved despite metformin monotherapy at a daily dose of ≥ 1500 mg.
  • The results of study D1690C00004 may be biased due to the shortcomings mentioned above and cannot be interpreted; consequently, the G-BA cannot make a valid assessment regarding the individual endpoints of the study.

c) Add-on combination therapy with other blood glucose-lowering medicinal products (other than metformin and insulin), where these do not adequately control blood glucose levels in conjunction with diet and exercise

• For patients being treated with add-on combination therapy comprising dapagliflozin and other blood glucose-lowering medicinal products (other than metformin and insulin), where these do not adequately control blood glucose levels in conjunction with diet and exercise, the additional benefit is not proven.
• In its assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that dapagliflozin offers no additional benefit compared with the appropriate comparator therapy of sulphonylureas (glibenclamide, glimepiride) + metformin.

d) Add-on combination therapy with insulin, where insulin therapy, in combination with diet and exercise, does not adequately control blood glucose

• For patients treated with add-on combination therapy of dapagliflozin and insulin, in whom insulin therapy, together with diet and exercise, does not adequately control blood glucose, the additional benefit is not proven.
• In its summary assessment of the methodological shortcomings described in the data submitted for this patient group, the G-BA concludes that no additional benefit of dapagliflozin has been established compared with the appropriate comparator therapy of metformin + human insulin or human insulin alone.

Courtesy translation only, please refer to the German original.