Insulin icodec (1) – Awiqli®

• Clinical trials
  • ONWARDS 1 is an open-label, randomised, active-controlled trial with a treatment duration of 78 weeks. The trial compared the administration of insulin icodec with that of insulin glargine, each in combination with non-insulin antidiabetic agents.
  • The open-label, randomised, active-controlled ONWARDS 4 trial investigates the comparison of insulin icodec with insulin glargin, each in combination with insulin aspart, in adults with prior experience of insulin therapy.

a1) Insulin-naïve adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current medication regimen consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy

• The additional benefit is not proven.
• Data from a sub-population of the ONWARDS 1 study were presented to assess the additional benefit of insulin icodec for the treatment of insulin-naïve adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their previous therapy consisting of at least two blood glucose-lowering medicinal products, and for whom there is an indication for insulin therapy for the first time, data from a patient population of the ONWARDS 1 study were presented.
• Overall, it cannot be reliably assumed that all participants had an indication for insulin therapy.
• Furthermore, the guideline recommendation for setting individualised target values for patients was not followed.
• Due to these limitations, no conclusions regarding the additional benefit of insulin icodec can be drawn from the ONWARDS 1 study.
• Overall assessment
  • Overall, the ONWARDS 1 study is not suitable for the present assessment.
  • Additional benefit is therefore not proven.

a2) Insulin-naïve adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current medication regimen consisting of at least two blood glucose-lowering medicinal products in addition to diet and exercise, and for whom there is an indication for insulin therapy

• An additional benefit is not proven.
• For the assessment of the additional benefit of insulin icodec for the treatment of insulin-naïve adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate glycaemic control with their previous therapy consisting of at least two glucose-lowering medicinal products, and for whom there is an indication for insulin therapy for the first time, no data were submitted.

b1) Insulin-experienced adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen in addition to diet and exercise

• The additional benefit is not proven.
• Data from a patient population of the ONWARDS 4 study were submitted for the assessment of the additional benefit of insulin icodec for the treatment of adults with type 2 diabetes mellitus without manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen.
• The ONWARDS 4 study is not suitable due to methodological limitations.
• Firstly, deviations from the recommendations of the clinical practice guidelines and the summary of product characteristics (SmPC) were observed.
• Secondly, it is not possible to conclusively assess whether the appropriate comparator therapy was correctly implemented.
• Overall, therefore, no conclusions regarding the additional benefit of insulin icodec in the treatment of insulin-experienced adults can be drawn on the basis of this study.
• Overall assessment
  • In summary, the ONWARDS 4 study is not suitable for the present assessment due to methodological limitations.
  • The additional benefit is therefore not proven.

b2) Insulin-experienced adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen in addition to diet and exercise

• An additional benefit is not proven.
• No data were submitted for the assessment of the additional benefit of insulin icodec for the treatment of adults with type 2 diabetes mellitus and manifest cardiovascular disease who have not achieved adequate blood glucose control with their current insulin regimen.

Courtesy translation only, please refer to the German original.