Insulin degludec (1) – Tresiba®

• 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.