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NCT05259033 · 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 Weekly Semaglutide (COMBINE 2)
A Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 683
- Enrollment target
- 20
- Study locations
NCT05259033: Completed Phase 3 study of Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S.
NCT05259033 is a Phase 3 study of Diabetes Mellitus, Type 2 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 683 participants, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (85% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05259033, a Phase 3 study of Diabetes Mellitus, Type 2, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 683 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week 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 semaglutide. Participants will either get IcoSema or semaglutide. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe semaglutide in many countries. Participants will get IcoSema or semaglutide, which they must inject once a week 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 have 18 clinic visits, 34 phone/video calls with the study doctor, and 4 contacts with the site that can either be clinic visits or phone/video calls. At 11 clinic visits participants will have blood samples taken. At 7 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.
Primary Outcome
Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died befor
Conditions Studied
Interventions
- DRUG IcoSema
- DRUG Semaglutide 1 mg
Study Locations (20)
Florida
- Northeast Research Institute - Fleming Island
- Northeast Res Inst. Inc. - Jacksonville
- Est Cst Inst for Rsrch,Jksnvil - Jacksonville
- South Broward Research LLC - Miramar
- Adult Medicine of Lake County, Inc. - Mt. Dora
- Florida Inst For Clin Res - Orlando
- Florida Institute For Clinical Research - Orlando
- Oviedo Medical Research, LLC - Oviedo
- Metabolic Research Institute Inc - West Palm Beach
California
- John Muir Physicians Network - Concord
- Velocity Clin Res Los Angeles - Los Angeles
- Velocity Clin Res Wstlke - Los Angeles
- Valley Clinical Trials, Inc. - Northridge
- Premier Medical Center, Inc. - Toluca Lake
Arizona
- Pri Med Grp dba/Gil Ctr Fam - Gilbert
- Clinical Research Institute of Arizona - Sun City West
Alabama
- Univ of AL at Birmingham_BRM - Birmingham
Georgia
- Javara/Privia Med Grp GA,LLC - Albany
Hawaii
- East West Med Res Inst - Honolulu
Idaho
- Saltzer Medical Group Research - Nampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 683 participants |
| Start Date | 2022-04-11 |
| Est. Completion | 2024-01-16 |
| Phase | Phase 3 |
What the finished NCT05259033 record still lists
NCT05259033 is an interventional study that assigns participants to a tested intervention. The registered 683 participants enrollment target is mid-sized for trials with a published cap, below the 4,483-participant average among 348 other Diabetes Mellitus, Type 2 trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 2 appearing as the primary indexed condition, and to 2 interventions - of which IcoSema is the first listed.
NCT05259033 names 20 study sites across 7 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05259033 about?
NCT05259033 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 Weekly Semaglutide (COMBINE 2)". This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to semaglutide taken once a week 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 ...
What is the current status of trial NCT05259033?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 683 participants. The study started on 2022-04-11. Estimated completion is 2024-01-16.
What conditions does trial NCT05259033 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 2.
What interventions are being tested in trial NCT05259033?
The interventions under investigation include: IcoSema (DRUG), Semaglutide 1 mg (DRUG).
Who is sponsoring clinical trial NCT05259033?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05259033 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 2
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05259033's enrollment target sits among peer trials
683 56th of 348 higher than 293 of 348 other Diabetes Mellitus, Type 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 2 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.
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