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 Insulin Icodec
Public ClinicalTrials.gov record NCT05352815. 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 Insulin Icodec, Both Treatment Arms With or Without Oral Anti Diabetic Drugs, in Participants With Type 2 Diabetes Inadequately Controlled With Daily Basal Insulin.
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 icodec 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 insulin icodec. Participants will either get IcoSema or insulin icodec. Which treatment participants get is decided by chance. IcoSema and insulin icodec are both new medicines that doctors cannot prescribe. Participants will get IcoSema or insulin icodec, which participants 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 21 clinic visits, 31 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. Not applicable for China: Participants will be asked to wear a sensor that measures their blood sugar level all the time during a 5 week period at the end of the study.
Study identification
- NCT ID
- NCT05352815
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,291 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
- May 31, 2022
- Primary completion
- Mar 18, 2024
- Completion
- Apr 22, 2024
- Last update posted
- Dec 3, 2025
2022 – 2024
United States locations
- U.S. sites
- 110
- U.S. states
- 34
- U.S. cities
- 93
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pri Med Grp dba/Gil Ctr Fam | Gilbert | Arizona | 85296 | — |
| Lenzmeier Fam Med CCT Research | Glendale | Arizona | 85308 | — |
| Phoenician Centers for Research & Innovation PCRI | Phoenix | Arizona | 85021 | — |
| Medical Investigations, Inc. | Little Rock | Arkansas | 72211 | — |
| John Muir Physicians Network | Concord | California | 94520 | — |
| Headlands Research California, LLC | Escondido | California | 92025 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| Clinical Trials Research_Sacramento | Lincoln | California | 95648 | — |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | — |
| Pacific Clinical Studies | Los Alamitos | California | 90720 | — |
| Downtown LA Res Ctr. Inc. | Los Angeles | California | 90017 | — |
| Velocity Clin Res Los Angeles | Los Angeles | California | 90017 | — |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | — |
| Clinical Trials Research_Sacramento_0 | Sacramento | California | 95821 | — |
| San Diego Family Care | San Diego | California | 92111 | — |
| NorCal Endocrinology and Internal Medicine | San Ramon | California | 94583 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80246 | — |
| Clinical Res Of W Florida Inc | Clearwater | Florida | 33765 | — |
| Northeast Research Institute | Fleming Island | Florida | 32003 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Adult Medicine of Lake County, Inc. | Mt. Dora | Florida | 32757 | — |
| Suncoast Clin Res Port Richey | New Port Richey | Florida | 34652 | — |
| Clinical Neuroscience Solution | Orlando | Florida | 32801 | — |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | — |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | — |
| Javara/Privia Med Grp GA,LLC | Albany | Georgia | 31707 | — |
| Emory University SOM | Atlanta | Georgia | 30303 | — |
| Javara Inc. | Fayetteville | Georgia | 30214 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | — |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | — |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | — |
| UnityPoint Health-Diabetes Care Center | Peoria | Illinois | 61603 | — |
| 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 | — |
| Barnum Medical Research Inc. | Natchitoches | Louisiana | 71457 | — |
| New Orleans Center for Clinical Research | New Orleans | Louisiana | 70119 | — |
| Ileana J Tandron APMC | Slidell | Louisiana | 70461-4231 | — |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115-5804 | — |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | — |
| Northern Pines Hlth Ctr, PC | Buckley | Michigan | 49620 | — |
| Elite Research Center | Flint | Michigan | 48532 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| StudyMetrix Research LLC | City of Saint Peters | Missouri | 63303 | — |
| Jefferson City Medical Group, PC | Jefferson City | Missouri | 65109 | — |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | — |
| University of NE Med Ctr | Omaha | Nebraska | 68198 | — |
| University of Nevada School of Medicine | Las Vegas | Nevada | 89102 | — |
| Palm Research Center Inc. | 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 | — |
| Mid Hudson Medical Research, PLLC | New Windsor | New York | 12553 | — |
| DiGiovanna Institute for Medical Education & Research | North Massapequa | New York | 11758-1802 | — |
| Endocrine Associates of Long Island, PC | Smithtown | New York | 11787 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| Javara Inc. / Tryon Medical Partners PLLC | Charlotte | North Carolina | 28287 | — |
| PharmQuest Life Sciences LLC | Greensboro | North Carolina | 27408 | — |
| Central Ohio Clinical Research LLC | Columbus | Ohio | 43213 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| New Venture Medical Research | Wadsworth | Ohio | 44281 | — |
| Intend Research | Norman | Oklahoma | 73069 | — |
| Care Access | Warwick | Rhode Island | 02886 | — |
| Palmetto Clinical Research | Summerville | South Carolina | 29485 | — |
| Athens Medical Group | Athens | Tennessee | 37303 | — |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| Holston Medical Group_Bristol | Bristol | Tennessee | 37620 | — |
| Chattanooga Medical Research, LLC | Chattanooga | Tennessee | 37404 | — |
| Univ Diab & Endo Consultants | Chattanooga | Tennessee | 37411 | — |
| HealthStar Physicians PC | Morristown | Tennessee | 37813 | — |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | — |
| Texas Diabetes & Endocrinology, P.A._Austin | Austin | Texas | 78731 | — |
| Texas Diabetes & Endocrinology, P.A._Austin | Austin | Texas | 78749 | — |
| Osvaldo A. Brusco MD PA | Corpus Christi | Texas | 78414 | — |
| Cedar Research | Dallas | Texas | 75038 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| Univ of TX SW Med Ctr Dallas | Dallas | Texas | 75390-9302 | — |
| Diabetes and Thyroid Ctr of FW | Fort Worth | Texas | 76132 | — |
| PrimeCare Medical Group | Houston | Texas | 77024 | — |
| Javara Inc. / Privia Medical Group Gulf Coast PLLC | Houston | Texas | 77054 | — |
| PlanIt Research, PLLC | Houston | Texas | 77079 | — |
| Protenium Clinical Research | Hurst | Texas | 76054 | — |
| Medical Colleagues-Texas LLP | Katy | Texas | 77450 | — |
| Andres Garcia-Zuniga, MD, P.A | Laredo | Texas | 78041 | — |
| Milton Haber, M.D. | Laredo | Texas | 78041 | — |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | — |
| Clinical Investigations Of Texas | Plano | Texas | 75075 | — |
| Texas Diabetes &Endocrinology | Round Rock | Texas | 78681 | — |
| Sun Research Institute | San Antonio | Texas | 78215 | — |
| Briggs Clinical Research, LLC | San Antonio | Texas | 78224 | — |
| Audie L. Murphy VA Hospital | San Antonio | Texas | 78229 | — |
| Diabetes & Gladular Disease Research A Cetero Research Co | San Antonio | Texas | 78229 | — |
| Diabetes Glandular Diseases Clinic | San Antonio | Texas | 78229 | — |
| Javara Inc Privia Grp Gulf Cst | San Marcos | Texas | 78666 | — |
| SimCare, PLLC | Sugar Land | Texas | 77478 | — |
| Sugar Lakes Family Practice PA | Sugar Land | Texas | 77479 | — |
| Hillcrest Family Health Center | Waco | Texas | 76708 | — |
| Javara Inc. / Privia Medical Group LLC_Appomattox | Appomattox | Virginia | 24522 | — |
| Javara Inc/Privia Md GpLLC Fst | Forest | Virginia | 24551 | — |
| Eastern Virginia Medical School | Norfolk | Virginia | 23510 | — |
| Amherst Family Practice P.C. | Winchester | Virginia | 22601 | — |
| Sound Medical Research | Port Orchard | Washington | 98366 | — |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | — |
| Ascension Columbia St. Mary's Hospital | 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 171 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05352815, 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 3, 2025 · Synced Sep 2, 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 protocol, eligibility criteria, and contact information for NCT05352815 live on ClinicalTrials.gov.