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NCT05013229 · ClinicalTrials.gov registry record · Phase 3
A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)
A Phase 3 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 679
- Enrollment target
NCT05013229 is a Phase 3 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 679 participants.
The verdict
NCT05013229, a Phase 3 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 679 participants
- Enrollment target
Study Summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 diabetes compared to insulin glargine taken with insulin aspart. Participants will either get IcoSema or insulin glargine taken with insulin aspart. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine and insulin aspart in many countries. Participants will get IcoSema or insulin glargine together with insulin aspart. Participants must inject IcoSema once a week or inject insulin glargine once daily and insulin aspart 2-4 times a day. Participants will inject the medicines with a pen, which has a small needle, in a skin fold in the thigh, upper arm, or stomach. The study will last for about 1 year and 1 month. Participants will be asked to wear a sensor that measures participants blood sugar level all the time during an 8 week period at the beginning of the study and a 4 week period at the end of the study. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Interventions
- DRUG Insulin glargine
- DRUG insulin aspart
- DRUG IcoSema
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 679 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2023-11-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05013229
The ClinicalTrials.gov registry entry for NCT05013229 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 679 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 glargine is the first listed.
NCT05013229 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05013229 about?
NCT05013229 is a clinical study titled "A Research Study to See How Well the New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Level in People With Type 2 Diabetes Compared to Insulin Glargine Taken Daily With Insulin Aspart (COMBINE 3)". This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine taken daily with insulin aspart in people with type 2 diabetes.The study will look at how well IcoSema controls blood sugar level in people with type 2 d...
What is the current status of trial NCT05013229?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 679 participants. The study started on 2021-11-30. Estimated completion is 2023-11-14.
What interventions are being tested in trial NCT05013229?
The interventions under investigation include: Insulin glargine (DRUG), insulin aspart (DRUG), IcoSema (DRUG).
Who is sponsoring clinical trial NCT05013229?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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