Insulin degludec (2) – Tresiba®

Diabetes mellitus type 2, combination with GLP-1 agonists

Characteristics

Start date 15.06.2014
Resolution 04.12.2014 repealed
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 Diabetes mellitus (DM type 1-2)
Reason for procedure New therapeutic indication
Repealed by: Insulin degludec (4) (16.05.2019)

Therapeutic indication of the resolution

Insulin degludec (Tresiba®) is indicated for the treatment of diabetes mellitus in adults.
Subpopulation Indication Comparator
Treatment of diabetes mellitus type 2 in combination with one or more other antidiabetic drugs Metformin + human insulin

Studies and Results

No. of studies
(best subpopulation) 		0 (no data submitted)
Study design
(best subpopulation) 		no data submitted (Dossier: )

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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