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NCT04760626 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,085
- Enrollment target
NCT04760626: Completed Phase 3 study, sponsored by Novo Nordisk A/S.
NCT04760626 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,085 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04760626, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,085 participants
- Enrollment target
Study 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 be planned to meet individual needs. At 6 clinic visits participants will have blood samples taken. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Primary Outcome
Change in HbA1c from baseline (week 0) to week 52 is presented.
Interventions
- DRUG Insulin icodec
- DRUG Insulin Degludec
- DRUG Insulin Glargine 100U/mL
- DRUG Insulin Glargine 300U/mL
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,085 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2022-08-29 |
| Phase | Phase 3 |
What the finished NCT04760626 record still lists
NCT04760626 is an interventional study that assigns participants to a tested intervention. Its 1,085 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (41% higher).
The record links to 0 conditions, and to 4 interventions - of which Insulin icodec is the first listed.
NCT04760626 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04760626 about?
NCT04760626 is a clinical study titled "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". 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...
What is the current status of trial NCT04760626?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,085 participants. The study started on 2021-03-01. Estimated completion is 2022-08-29.
What interventions are being tested in trial NCT04760626?
The interventions under investigation include: Insulin icodec (DRUG), Insulin Degludec (DRUG), Insulin Glargine 100U/mL (DRUG), Insulin Glargine 300U/mL (DRUG).
Who is sponsoring clinical trial NCT04760626?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04760626's enrollment target sits among peer trials
1,085 269th of 2000 higher than 1,732 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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