A 52-week study comparing the efficacy and safety of once weekly IcoSema and once weekly insulin Icodec, both treatment arms with or without oral anti-diabetic drugs, in participants with type 2 diabetes inadequately controlled with daily basal insulin. COMBINE 1

  • sponsor
    Novo Nordisk
Updated on 1 June 2023


Objective: To confirm superiority of once weekly IcoSema compared with once weekly insulin Icodec, both treatment arms with or without OADs, in terms of glycaemic control measured by change in HbA1c from baseline after 52 weeks in participants with T2D inadequately controlled with daily basal insulin.


Study duration is approximately 59 weeks and consists of:
  • 2 weeks screening period
  • 52 weeks treatment period
  • 5 weeks follow-up period
25 Visits - $50
31 Televisits - $25
Total - $2,025
Study Medication:
  • IcoSema- 700 units/mL + 2 mg/mL, subcutaneous, solution for injection, 1.5 mL pre-filled PDS290 pen injector.
  • Insulin icodec- 700 units/mL, subcutaneous, solution for injection, 3 mL pre-filled PDS290 pen-injector

Condition Diabetes Mellitus Types I and II
Clinical Study IdentifierTX307742
SponsorNovo Nordisk
Last Modified on1 June 2023

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