Insulin degludec / Liraglutid (2) – Xultophy®

• Clinical trials
  • The pharmaceutical manufacturer’s research, conducted for the purpose of an indirect comparison, identified the DUAL III trial. In this randomised controlled trial, insulin degludec/liraglutide was compared with the continuation of existing treatment with a GLP-1 receptor agonist.

Insulin degludec/liraglutide in combination with oral hypoglycaemic medicinal products for the treatment of type 2 diabetes mellitus in adults, when these, in combination with a GLP-1 receptor agonist, are insufficient to control blood glucose levels

• For the combination of insulin degludec/liraglutide with oral antidiabetic agents in patients for whom oral antidiabetic agents in combination with a GLP-1 receptor agonist are insufficient for blood glucose control, there is no evidence of additional benefit compared with the appropriate comparator therapy (metformin plus human insulin or human insulin alone, if metformin is not suitable according to the SmPC) has not been proven.
• The pharmaceutical manufacturer did not identify any relevant study providing a direct comparison between insulin degludec/liraglutide and the appropriate comparator therapy determined by the G-BA.
• However, the pharmaceutical manufacturer was unable to find a study on the appropriate comparator therapy.
• For the sub-indication ‘Metformin not suitable according to the SmPC’, the pharmaceutical manufacturer also failed to submit any relevant studies suitable for an indirect comparison.
• Overall assessment
  • An additional benefit of insulin degludec/liraglutide over the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.