Ertugliflozin / Sitagliptin (1) – Steglujan®

• Clinical trials
  • For the benefit assessment pursuant to Section 35a of the German Social Code, Book V (SGB V), the pharmaceutical manufacturer draws on the randomised, double-blind, placebo-controlled, multicentre registration trial VERTIS SITA 2 for an indirect comparison.

Adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin; in this case, metformin and/or sulphonylurea and ertugliflozin or sitagliptin)

• For adult patients with type 2 diabetes mellitus whose condition is not adequately controlled by treatment with at least two blood glucose-lowering medicinal products (excluding insulin; in this case, metformin and/or a sulphonylurea and ertugliflozin or sitagliptin) are not adequately controlled, an additional benefit is not proven.
• An additional benefit is not proven.
• The pharmaceutical manufacturer has not submitted any randomised controlled trials (RCTs) that allow for a direct comparison with the appropriate comparator therapy.
• The VERTIS SITA 2 study is not used for the benefit assessment, as it does not contain suitable data allowing a direct comparison of ertugliflozin/sitagliptin with the appropriate comparator therapy.
• For an indirect comparison, no relevant studies using the bridging comparator were identified that would have been suitable for assessing the additional benefit compared with the appropriate comparator therapy.
• Overall, there are therefore no data available for assessing the additional benefit of ertugliflozin/sitagliptin compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.