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
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
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
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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