Rationale and design of the phase 3a development programme ( ONWARDS 1–6 trials) investigating once‐weekly insulin icodec in diabetes
Study context
- Population
- Adults with T2D (insulin-naive: ONWARDS 1, 3 and 5; previously insulin-treated: ONWARDS 2 and 4) and T1D (ONWARDS 6)6 RCTs
- Planned comparison
- Once-weekly insulin icodec vs daily basal insulin
- Primary endpoint
- Change in HbA1c from baseline, icodec vs comparator arms
- Follow-up
- Week 26 or week 52
Methodological detailssix RCTs (ONWARDS 1–6), ONWARDS 5 incorporates real-world elements and a digital dose titration solution to guide icodec dosing, Secondary objectives: other glycaemic control and safety parameters (fasting glucose, time in glycaemic range, hypoglycaemia); patient-reported treatment satisfaction
- Six RCTs (ONWARDS 1–6)
- ONWARDS 5 incorporates real-world elements and a digital dose titration solution to guide icodec dosing
- Secondary objectives: other glycaemic control and safety parameters (fasting glucose, time in glycaemic range, hypoglycaemia); patient-reported treatment satisfaction
No results yet. This paper sets out the design of a trial; its results are to come.
Original publication
Rationale and design of the phase 3a development programme ( ONWARDS 1–6 trials) investigating once‐weekly insulin icodec in diabetes. Diabetes Obes Metab. Published 14 October 2022. doi:10.
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