Insulin degludec (1) – Tresiba®

Diabetes mellitus type 1 and type 2

Characteristics

Start date 01.05.2014 – Marketing authorisation: 20.01.2013
Resolution 16.10.2014 repealed subpopulations
INN Insulin degludec
Brand name Tresiba®
Pharm. company Novo Nordisk Pharma GmbH
G-BA Procedure ID D-109
ATC code A10AE06 Insulins and analogues for injection, long-acting (A10AE)
ICD-10 codes (AIS) E10.01, E10.11Type 1 diabetes mellitus with ketoacidosis with coma, E10.20, E10.21Type 1 diabetes mellitus with intercapillary glomerulosclerosis, E10.30, E10.31Type 1 diabetes mellitus with unspecified diabetic retinopathy with macular edema, E10.40Type 1 diabetes mellitus with diabetic neuropathy, unspecified, E10.41Type 1 diabetes mellitus with diabetic mononeuropathy, E10.50, E10.51Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene, E10.60, E10.61Type 1 diabetes mellitus with diabetic neuropathic arthropathy, E10.72, E10.73, E10.74, E10.75, E10.80, E10.81, E10.90, E10.91, E12.01, E12.11, E12.20, E12.21, E12.30, E12.31, E12.40, E12.41, E12.50, E12.51, E12.60, E12.61, E12.72, E12.73, E12.74, E12.75, E12.80, E12.81, E12.91, E13.01Other specified diabetes mellitus with hyperosmolarity with coma, E13.11Other specified diabetes mellitus with ketoacidosis with coma, E13.20, E13.21Other specified diabetes mellitus with intercapillary glomerulosclerosis, E13.30, E13.31Other specified diabetes mellitus with unspecified diabetic retinopathy with macular edema, E13.40Other specified diabetes mellitus with diabetic neuropathy, unspecified, E13.41Other specified diabetes mellitus with diabetic mononeuropathy, E13.50, E13.51Other specified diabetes mellitus with diabetic peripheral angiopathy without gangrene, E13.60, E13.61Other specified diabetes mellitus with diabetic neuropathic arthropathy, E13.72, E13.73, E13.74, E13.75, E13.80, E13.81, E13.90, E13.91, E14.01, E14.11, E14.20, E14.21, E14.30, E14.31, E14.40, E14.41, E14.50, E14.51, E14.60, E14.61, E14.72, E14.73, E14.74, E14.75, E14.80, E14.81, E14.90, E14.91 Show more >>
Alpha-ID codes (AIS) I110911Diabetic foot syndrome, I110976Diabetes mellitus with eye complications, I110978Diabetes mellitus with neurological complications, I111029Diabetes mellitus with complication, I111031Diabetes mellitus with vascular complication, I111458Secondary diabetes mellitus, I111462Diabetic derailment, I115659Type 1 diabetes mellitus with diabetic foot syndrome, I116677Diabetes mellitus type I, I120115Deregulated diabetes mellitus type 1, I127364Insulin resistance syndrome, type A, I127626Wolfram syndrome, I2202Diabetes mellitus without complications, I25564Diabetes mellitus with coma, I31391Diabetes mellitus with multiple complications, I97452Diabetes mellitus with hypoglycemia, I98004Diabetes mellitus with ketoacidosis, I98511Hypoglycemic coma in diabetes mellitus, I98993Type 1 diabetes mellitus with coma, I98994Type 1 diabetes mellitus with ketoacidosis, I99100Diabetic gangrene in type 1 diabetes mellitus, I99123Type 1 diabetes mellitus with multiple complications, I99128Complication of type 1 diabetes mellitus, I99134Hypoglycemic coma in type 1 diabetes mellitus, I99137Sexual dysfunction in type 1 diabetes mellitus
DDD 40 U P
Therapeutic area Metabolic diseases Diabetes mellitus (DM type 1-2)
Reason for procedure Initial assessment
Repealed by: Insulin degludec (4) (16.05.2019)

Therapeutic indication of the resolution

Treatment of diabetes mellitus in adults.
Subpopulation Indication Comparator
a) Monotherapy for the treatment of diabetes mellitus type 2 in adults Human insulin
b) Combination therapy with one or more oral antidiabetic agents for the treatment of diabetes mellitus type 2 in adults Metformin plus human insulin (if necessary, therapy with human insulin only)
c) Combination therapy with bolus insulin (with or without one or more oral antidiabetic agents) for the treatment of type 2 diabetes mellitus in adults. Human insulin plus metformin if necessary
d) Treatment of diabetes mellitus type 1 in adults Human insulin

Studies and Results

No. of studies
(best subpopulation) 		1 (NN1250-3770,)
Study design
(best subpopulation) 		H2H vs. ACT (off-label)
Meta analysis
(best subpopulation) 		no
Reason for dividing into subpopulations (G-BA) Number of medications, Gene/mutation specifics

  • Clinical trials
    • In this three-arm, open-label, randomised, multicentre Phase IIItrial with a treatment duration of 26 weeks, the efficacy and safety of insulin degludec alone or in combination with oral antidiabetic agents, as well as the insulin analogue insulin glargine alone or in combination with oral antidiabetic agents, were investigated.
    • To demonstrate the additional benefit of insulin degludec in combination with one or more oral antidiabetic agents, the pharmaceutical manufacturer submitted the following four studies: NN1250-3586, NN1250-3668, NN1250-3579 and NN1250-3672.
    • Study NN1250-3668 is a 26-week, open-label, randomised, three-arm study comparing the efficacy and safety of insulin degludec at varying injection times (defined intervals of 8–40 hours between doses; 229 patients), insulin degludec as an evening injection (228 patients) and insulin glargine (230 patients), each in combination with oral antidiabetic agents.
    • Studies NN1250-3579 and NN1250-3672 were open-label, multicentre, randomised Phase III studies with a treatment period of 52 weeks (study NN1250-3579) and 26 weeks (study NN1250-3672), respectively.

a) Monotherapy for the treatment of type 2 diabetes mellitus in adults

  • For monotherapy with insulin degludec for the treatment of type 2 diabetes mellitus in adults, the additional benefit compared with the appropriate comparator therapy, human insulin, is not proven.
  • The pharmaceutical manufacturer did not submit any results for this study or the relevant patient population due to the minor sample size. Consequently, no evaluable data are available for assessing the additional benefit of insulin degludec as monotherapy compared with the appropriate comparator therapy (human insulin); the additional benefit compared with the appropriate comparator therapy (human insulin) is therefore not proven.

b) Combination therapy with one or more oral antidiabetic agents for the treatment of type 2 diabetes mellitus in adults

  • For combination therapy with insulin degludec and one or more oral antidiabetic agents for the treatment of type 2 diabetes mellitus in adults, the additional benefit compared with the appropriate comparator therapy of metformin plus human insulin (or human insulin alone, where applicable) is not proven.
  • The dossier submitted by the pharmaceutical manufacturer does not meet the requirements set out in Section 9(3), first sentence, of the VerfO. Consequently, there is no comprehensive data set available for the assessment of the added benefit of insulin degludec in combination with one or more oral antidiabetic agents compared with the appropriate comparator therapy (metformin plus human insulin, or human insulin alone, where applicable). The additional benefit compared with the appropriate comparator therapy is not proven.

c) Combination therapy with bolus insulin (with or without one or more oral antidiabetic agents) for the treatment of type 2 diabetes mellitus in adults

  • For combination therapy with insulin degludec and bolus insulin (with or without one or more oral antidiabetic agents) for the treatment of type 2 diabetes mellitus in adults, the additional benefit compared with the appropriate comparator therapy—human insulin, with or without metformin—is not proven.
  • The dossier submitted by the pharmaceutical manufacturer does not meet the requirements set out in Section 9(3), first sentence, of the VerfO. Consequently, there is no comprehensive data set available for the assessment of the added benefit of insulin degludec in combination with bolus insulin (with or without one or more oral antidiabetic agents) compared with the appropriate comparator therapy (human insulin plus, where applicable, metformin). The additional benefit compared with the appropriate comparator therapy is therefore not proven.

d) Treatment of type 1 diabetes mellitus in adults

  • For insulin degludec in the treatment of type 1 diabetes mellitus in adults, the additional benefit compared with the appropriate comparator therapy, human insulin, is not proven.
  • The dossier submitted by the pharmaceutical manufacturer does not meet the requirements set out in Section 9(3), first sentence, of the VerfO. Consequently, there is no comprehensive data set available for the assessment of the additional benefit of insulin degludec for the treatment of type 1 diabetes mellitus compared with the appropriate comparator therapy (human insulin). The additional benefit compared with the appropriate comparator therapy is therefore not proven.

Courtesy translation only, please refer to the German original.

Associated procedures



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