A Research Study to Compare a New Weekly Insulin, Insulin Icodec Used With DoseGuide App, and Daily Insulins in People With Type 2 Diabetes Who Have Not Used Insulin Before
Phase 3
Completed
NCT04760626
| Condition | Diabetes Mellitus, Type 2 |
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| Phase | Phase 3 |
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| Sponsor | Novo Nordisk A/S |
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| Status | Completed |
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| Enrollment | 1,085 participants |
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| Interventions | Insulin icodec, Insulin Glargine 100U/mL, Insulin Degludec, Insulin Glargine 300U/mL |
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| Start date | Mar 1, 2021 |
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| Completion date | Aug 12, 2022 |
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| Results posted | Aug 26, 2025 |
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Summary
This study compares insulin icodec to different daily insulins in people with type 2 diabetes. The study will look at how well insulin icodec taken once weekly controls blood sugar compared to the insulins taken once daily. Participants will either get insulin icodec, that participants will have to inject once a week on the same day of the week, or a marketed insulin, that participants will have to inject once a day. Which treatment participants get is decided at random. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. Participants will measure their blood sugar every day. Participants will get a study phone to record safety data in the electronic diary (eDiary). If participants get a daily insulin they will record their insulin doses in the eDiary. If Participants get weekly insulin icodec, participants study phone will also have the DoseGuide App. The DoseGuide App gives dose recommendations based on their blood sugar and previous doses. Participants will record their insulin doses in the DoseGuide App. The study will last for about 1 year and 2 months. Participants will have 8 planned clinic visits with the study doctor. More visits will b
Change in Glycated Haemoglobin (HbA1c)
Baseline (week 0), week 52 · Percentage of HbA1c
| Insulin Icodec | -1.68 ± 0.09 Percentage of HbA1c |
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| Once Daily Basal Insulin Analogue | -1.31 ± 0.12 Percentage of HbA1c |
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| p-value | <0.0001 |
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| Treatment difference | -0.38 (95% CI -0.66–-0.09) |
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Open in BENITIONS
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