Insulin degludec (2) – Tresiba®

Diabetes mellitus type 2, combination with GLP-1 agonists

Characteristics

Start date 15.06.2014
Resolution 04.12.2014
INN Insulin degludec
Brand name Tresiba®
Pharm. company Novo Nordisk Pharma GmbH
G-BA Procedure ID D-118
ATC code A10AE06 Insulins and analogues for injection, long-acting (A10AE)
DDD 40 U P
Therapeutic area Metabolic diseases
Reason for procedure New therapeutic indication
Reassessed in: Insulin degludec (4) (16.05.2019)

Studies and Results

Treatment of type 2 diabetes mellitus in combination with one or more other antidiabetic medicines (excluding insulin)

  • As the necessary proof has not been provided, 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 appropriate comparator therapy for insulin degludec in the treatment of type 2 diabetes mellitus in combination with one or more other antidiabetic agents (excluding insulin) is:
  • metformin plus human insulin
  • (Indication: Where appropriate, treatment with human insulin alone may be used if metformin is not sufficiently effective or is not suitable according to the SmPC).
  • Overall assessment
    • In summary, the additional benefit of insulin degludec (new indication) is assessed as follows:
    • As the necessary evidence has not been provided, 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)).

Courtesy translation only, please refer to the German original.

Associated procedures



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