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NCT04880850 · ClinicalTrials.gov registry record · Phase 3
A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 582
- Enrollment target
NCT04880850 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 582 participants.
The verdict
NCT04880850, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 582 participants
- Enrollment target
Study Summary
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants will get is decided by chance. Participants will also get a mealtime insulin.The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 8 months. participants will have 17 clinic visits and 13 phone calls with the study doctor.At 8 clinic visits participants will have blood samples taken. At 4 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Interventions
- DRUG Insulin aspart
- DRUG Insulin icodec
- DRUG Insulin glargine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2021-05-14 |
| Est. Completion | 2022-06-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04880850
The ClinicalTrials.gov registry entry for NCT04880850 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 582 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 3 interventions - of which Insulin aspart is the first listed.
NCT04880850 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04880850 about?
NCT04880850 is a clinical study titled "A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)". This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargi...
What is the current status of trial NCT04880850?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2021-05-14. Estimated completion is 2022-06-16.
What interventions are being tested in trial NCT04880850?
The interventions under investigation include: Insulin aspart (DRUG), Insulin icodec (DRUG), Insulin glargine (DRUG).
Who is sponsoring clinical trial NCT04880850?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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