A Research Study to See How Well New Weekly Medicine IcoSema, Which is a Combination of Insulin Icodec and Semaglutide, Controls Blood Sugar Levels in People With Type 2 Diabetes (T2D), Compared to Daily Insulin Glargine (COMBINE 4)
Public ClinicalTrials.gov record NCT06269107. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 40-week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL in Participants With Type 2 Diabetes Inadequately Controlled on Oral Anti Diabetic Drugs COMBINE 4
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study will compare the new medicine IcoSema, which is a combination of insulin icodec and semaglutide, taken once a week, to insulin glargine (mentioned as insulin glargine in this form) taken daily in people with type 2 diabetes. The study will look at how well IcoSema controls blood sugar levels as compared to insulin glargine in people with type 2 diabetes who do not have their blood sugar properly controlled with other oral diabetes medicines. Participant will either get IcoSema or insulin glargine. Which treatment participants get is decided by chance. IcoSema is a new medicine that doctors cannot prescribe. Doctors can already prescribe insulin glargine in many countries. The study will last for about 11 months (47 weeks).
Study identification
- NCT ID
- NCT06269107
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 485 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 14, 2024
- Primary completion
- May 26, 2025
- Completion
- Jul 7, 2025
- Last update posted
- Jun 4, 2026
2024 – 2025
United States locations
- U.S. sites
- 43
- U.S. states
- 20
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama_Birmingham | Birmingham | Alabama | 35233 | — |
| John Muir Physicians Network | Concord | California | 94520 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| First Valley Med Grp Lancaster | Lancaster | California | 93534 | — |
| Clinical Trials Research_Sacramento | Lincoln | California | 95821 | — |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 91355 | — |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | — |
| Northeast Research Institute | Fleming Island | Florida | 32003 | — |
| East Coast Institute For Research | Jacksonville | Florida | 32208 | — |
| Clinical Research of Cent FL | Winter Haven | Florida | 33880 | — |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | — |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | — |
| East West Medical Research Institute_Honolulu | Honolulu | Hawaii | 96814 | — |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| Endeavor Health | Skokie | Illinois | 60077 | — |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | — |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | — |
| Endo and Metab Consultants | Rockville | Maryland | 20852 | — |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | — |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| AMC Community Endocrinology | Albany | New York | 12203 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | — |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | — |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | — |
| Advanced Medical Research | Maumee | Ohio | 43537 | — |
| New Venture Medical Research | Wadsworth | Ohio | 44281-9236 | — |
| Essential Medical Research LLC | Tulsa | Oklahoma | 74137 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | — |
| Velocity Clinical Research- Cedar Park | Austin | Texas | 78759 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | — |
| Fmc Science, Llc | Lampasas | Texas | 76550 | — |
| Epic Medical Research | Red Oak | Texas | 75154 | — |
| Quality Research Inc | San Antonio | Texas | 78209 | — |
| Flourish Research | San Antonio | Texas | 78229 | — |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | — |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | — |
| Wade Family Medicine | Bountiful | Utah | 84010 | — |
| TPMG Clinical Research | Newport News | Virginia | 23606 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06269107, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 4, 2026 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06269107 live on ClinicalTrials.gov.