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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 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 1,085 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04760626
The ClinicalTrials.gov registry entry for NCT04760626 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,085 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Insulin icodec is the first listed.
NCT04760626 reports 0 study locations.
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.
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