Linagliptin (3) – Trajenta®

• Clinical trials
  • Despite being requested to do so, the pharmaceutical manufacturer had not submitted a dossier to the Federal Joint Committee (G-BA) by the relevant date.

Patients with type 2 diabetes mellitus for whom treatment with linagliptin in combination with insulin, with or without metformin, in addition to diet and exercise, is insufficient to control blood glucose levels

• As the required proof has not been submitted in full, the additional benefit in relation to the appropriate comparator therapy is deemed not proven (Section 35a(1), fifth sentence, of Book V of the Social Code [SGB V]).
• The G-BA notes that the pharmaceutical manufacturer has not submitted the evidence required under Section 35a(1) in conjunction with Chapter 5, Section 9 of the VerfO for the benefit assessment of the medicinal product.
• Appropriate comparator therapy
  • The appropriate comparator therapy for linagliptin in combination with insulin, with or without metformin, where this treatment alone, together with diet and exercise, is insufficient to control blood glucose levels in patients with type 2 diabetes mellitus, is: the dual combination of metformin and human insulin
  • (Indication: Treatment with human insulin alone if metformin is not tolerated or is not sufficiently effective, as stated in the summary of product characteristics (SmPC))

Courtesy translation only, please refer to the German original.