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)
Public ClinicalTrials.gov record NCT05013229. 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 52 Week Study Comparing the Efficacy and Safety of Once Weekly IcoSema and Daily Insulin Glargine 100 Units/mL Combined With Insulin Aspart, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin. COMBINE 3
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 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.
Study identification
- NCT ID
- NCT05013229
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 679 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
- Nov 30, 2021 (Actual)
- Primary completion
- Nov 14, 2023 (Actual)
- Completion
- Nov 14, 2023 (Actual)
- Last update posted
- Dec 2, 2025
2021 – 2023
United States locations
- U.S. sites
- 66
- U.S. states
- 30
- U.S. cities
- 62
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lakeview Clinical Research, LLC | Guntersville | Alabama | 35976 | — |
| Valley Research | Fresno | California | 93720 | — |
| Scripps Wht Diab Inst La Jolla | La Jolla | California | 92037 | — |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | — |
| Downtown LA Res Ctr. Inc. | Los Angeles | California | 90017 | — |
| San Diego Family Care | San Diego | California | 92111 | — |
| NorCal Endocrinology and Internal Medicine | San Ramon | California | 94583 | — |
| Creekside Endocrine Associates | Denver | Colorado | 80209 | — |
| Clinical Res Of W Florida Inc | Clearwater | Florida | 33765 | — |
| Northeast Research Institute | Fleming Island | Florida | 32003 | — |
| Sweet Hope Research Specialty | Hialeah | Florida | 33016 | — |
| E Coast Inst for Rsrch LLC_Jacksonville | Jacksonville | Florida | 32204 | — |
| Northeast Res Inst. Inc. | Jacksonville | Florida | 32204 | — |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | — |
| South Broward Research LLC | Miramar | Florida | 33027 | — |
| Adult Medicine of Lake County, Inc. | Mt. Dora | Florida | 32757 | — |
| Renstar Medical Research | Ocala | Florida | 34470 | — |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | — |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | — |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | — |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | — |
| Endeavor Health | Skokie | Illinois | 60077 | — |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | — |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | — |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | — |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | — |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | — |
| ActivMed Practice & Research LLC | Methuen | Massachusetts | 01844 | — |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | — |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | — |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198-3020 | — |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | — |
| Southern NH Diabetes and Endocrinology | Nashua | New Hampshire | 03060 | — |
| John J Shelmet, MD | Lawrenceville | New Jersey | 08648 | — |
| Mid Hudson Med Res-New Windsor | New Windsor | New York | 12553 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758-1802 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | — |
| Piedmont Healthcare/Research | Statesville | North Carolina | 28625 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | — |
| Central Ohio Clinical Research LLC | Columbus | Ohio | 43213 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| New Venture Medical Research | Wadsworth | Ohio | 44281 | — |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | — |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| Univ Diab & Endo Consultants | Chattanooga | Tennessee | 37411 | — |
| HealthStar Physicians PC | Morristown | Tennessee | 37813 | — |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| PrimeCare Medical Group | Houston | Texas | 77024 | — |
| PlanIt Research, PLLC | Houston | Texas | 77079 | — |
| Protenium Clinical Research | Hurst | Texas | 76054 | — |
| Andres Garcia-Zuniga, MD, P.A | Laredo | Texas | 78041 | — |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | — |
| Clinical Investigations Of Texas | Plano | Texas | 75075 | — |
| Briggs Clinical Research, LLC | San Antonio | Texas | 78224 | — |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | — |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
| Amherst Family Practice P.C. | Winchester | Virginia | 22601 | — |
| Sound Medical Research | Port Orchard | Washington | 98366 | — |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | — |
| Ascension Medical Group- Germantown Clinic | Milwaukee | Wisconsin | 53211 | — |
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 116 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05013229, 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 Dec 2, 2025 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05013229 live on ClinicalTrials.gov.