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

  • STATUS
    Recruiting
  • sponsor
    Novo Nordisk
Updated on 1 June 2023

Summary

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.

Description

Duration:
Study duration is approximately 59 weeks and consists of:
  • 2 weeks screening period
  • 52 weeks treatment period
  • 5 weeks follow-up period
Compensation:
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

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

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