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)
Public ClinicalTrials.gov record NCT05259033. 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 Once Weekly Semaglutide, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With a GLP 1 Receptor Agonist. COMBINE 2
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 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.
Study identification
- NCT ID
- NCT05259033
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 683 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
- Apr 11, 2022 (Actual)
- Primary completion
- Dec 13, 2023 (Actual)
- Completion
- Jan 16, 2024 (Actual)
- Last update posted
- Jun 12, 2026
2022 – 2024
United States locations
- U.S. sites
- 76
- U.S. states
- 30
- U.S. cities
- 68
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of AL at Birmingham_BRM | Birmingham | Alabama | 35294 | — |
| Pri Med Grp dba/Gil Ctr Fam | Gilbert | Arizona | 85296 | — |
| Phoenician Centers for Research & Innovation PCRI | Phoenix | Arizona | 85021 | — |
| Clinical Research Institute of Arizona | Sun City West | Arizona | 85375 | — |
| John Muir Physicians Network | Concord | California | 94520 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| Clinical Trials Research_Sacramento | Lincoln | California | 95821 | — |
| Downtown LA Res Ctr. Inc. | Los Angeles | California | 90017 | — |
| Velocity Clin Res Los Angeles | Los Angeles | California | 90017 | — |
| Velocity Clin Res Wstlke | Los Angeles | California | 90057 | — |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | — |
| San Diego Family Care_San Diego | San Diego | California | 92111 | — |
| Premier Medical Center, Inc. | Toluca Lake | California | 91602 | — |
| Northeast Research Institute | Fleming Island | Florida | 32003 | — |
| Encore Medical Research LLC | Hollywood | Florida | 33024 | — |
| Northeast Res Inst. Inc. | Jacksonville | Florida | 32204 | — |
| Est Cst Inst for Rsrch,Jksnvil | Jacksonville | Florida | 32216 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| South Broward Research LLC | Miramar | Florida | 33027 | — |
| Adult Medicine of Lake County, Inc. | Mt. Dora | Florida | 32757 | — |
| Clinical Neuroscience Solution | Orlando | Florida | 32801 | — |
| Florida Institute For Clinical Research | Orlando | Florida | 32825 | — |
| Oviedo Medical Research, LLC | Oviedo | Florida | 32765 | — |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | — |
| Javara/Privia Med Grp GA,LLC | Albany | Georgia | 31707 | — |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | — |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | — |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| Macoupin Research Group | Gillespie | Illinois | 62033 | — |
| Endeavor Health | Skokie | Illinois | 60077 | — |
| Central Illinois Diabetes and Clinical Research | Springfield | Illinois | 62711 | — |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | — |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | — |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | — |
| L-MARC Research Center | Louisville | Kentucky | 40213 | — |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | 42001 | — |
| Ileana J Tandron APMC | Slidell | Louisiana | 70461-4231 | — |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | — |
| ActivMed Practice & Research LLC | Methuen | Massachusetts | 01844 | — |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | — |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198-3020 | — |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | — |
| Southern New Hampshire Diabete | Nashua | New Hampshire | 03060 | — |
| John J Shelmet, MD | Lawrenceville | New Jersey | 08648 | — |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| Endocrine Associates of Long Island, PC | Smithtown | New York | 11787 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | — |
| New Venture Medical Research | Wadsworth | Ohio | 44281 | — |
| Thomas Jefferson Univ Di Rsrch Ctr | Philadelphia | Pennsylvania | 19107 | — |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | — |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | — |
| Texas Diab & Endo, P.A. | Austin | Texas | 78731 | — |
| Texas Diabetes & Endocrinology | Austin | Texas | 78749 | — |
| Osvaldo A. Brusco MD | Corpus Christi | Texas | 78414 | — |
| Cedar Research | Dallas | Texas | 75038 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | — |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | — |
| PrimeCare Medical Group | Houston | Texas | 77024 | — |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | — |
| Texas Diabetes & Endocrinology_Round Rock | Round Rock | Texas | 78681 | — |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | — |
| Sugar Lakes Family Practice PA | Sugar Land | Texas | 77479 | — |
| Hillcrest Family Health Center | Waco | Texas | 76710 | — |
| Wade Family Medicine | Bountiful | Utah | 84010 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
| Javara Inc. / Privia Medical Group LLC_Forest | Forest | Virginia | 24551 | — |
| Javara Inc/Privia Md GpLLC Fst | Forest | Virginia | 24551 | — |
| 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 117 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05259033, 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 12, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05259033 live on ClinicalTrials.gov.