A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Glargine, in People With Type 2 Diabetes Who Have Not Used Insulin Before
Public ClinicalTrials.gov record NCT04460885. 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 78-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Treatment, in Insulin naïve Subjects With Type 2 Diabetes
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compares insulin icodec (a new insulin taken once a week) to insulin glargine (an insulin taken once daily which is already available on the market) in people with type 2 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin glargine taken daily. Participants will either get insulin icodec that participants will have to inject once a week on the same day of the week or insulin glargine that participants will have to inject once a day at the same time every day. Which treatment participants get is decided by chance. The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 1 ½ years. Participants will have 37 clinic visits and 26 phone calls with the study doctor. At 11 clinic visits participant will have blood samples taken. At 8 clinic visits participants cannot eat or drink (except for water) for 8 hours before the visit. Participants will be asked to wear a sensor that measures the blood sugar all the time in 5 periods of about one month during the study (about 5 months in total). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Study identification
- NCT ID
- NCT04460885
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 984 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 25, 2020 (Actual)
- Primary completion
- May 29, 2022 (Actual)
- Completion
- Dec 1, 2022 (Actual)
- Last update posted
- Dec 4, 2025
2020 – 2022
United States locations
- U.S. sites
- 97
- U.S. states
- 33
- U.S. cities
- 88
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Uni of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Lakeview Clinical Research, LLC | Guntersville | Alabama | 35976 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | — |
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| Advanced Clinical Research/Rancho Paseo Medical Group | Banning | California | 92220 | — |
| American Clinical Trials | Buena Park | California | 90620 | — |
| San Fernando Valley Hlth Inst, LLC | Canoga Park | California | 91304 | — |
| Med Center Medical Clinic | Carmichael | California | 95608 | — |
| Headlands Research California, LLC | Escondido | California | 92025 | — |
| Valley Research | Fresno | California | 93720 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| First Valley Medical Group | Lancaster | California | 93534 | — |
| Clinical Trials Research_Sacramento | Lincoln | California | 95648 | — |
| Torrance Clin Res Inst, Inc. | Lomita | California | 90717 | — |
| Providence Clinical Research | North Hollywood | California | 91606 | — |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | — |
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | — |
| NorCal Endocrinology and Internal Medicine_Roseville | Roseville | California | 95661 | — |
| Diabetes Research Center | Tustin | California | 92780 | — |
| Coastal Metabolic Research Center | Ventura | California | 93003 | — |
| Denver Endocrinology Diabetes and Thyroid Center | Englewood | Colorado | 80113 | — |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | — |
| Revival Research | Doral | Florida | 33122 | — |
| East Coast Institute for Research, LLC | Jacksonville | Florida | 32216 | — |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| Suncoast Clin Res Port Richey | New Port Richey | Florida | 34652 | — |
| Florida Inst For Clin Res | Orlando | Florida | 32825 | — |
| Palm Harbor Medical Associates | Palm Harbor | Florida | 34684-3609 | — |
| Suncoast Clinical Research, Inc. | Palm Harbor | Florida | 34684 | — |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | — |
| Clinical Research of Cent FL | Winter Haven | Florida | 33880 | — |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| RNA America Health Sciences | Sugar Hill | Georgia | 30518 | — |
| East West Medical Research Institute_Honolulu | Honolulu | Hawaii | 96814 | — |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| Clinical Invest Special_Gurnee | Gurnee | Illinois | 60031 | — |
| Central Illinois Diabetes and Clinical Research | Springfield | Illinois | 62711 | — |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | — |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | — |
| St Elizabeth Physicians Heart | Covington | Kentucky | 41011 | — |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | 42001 | — |
| MedStar Hlth Res Institute | Hyattsville | Maryland | 20782 | — |
| Endo And Metab Cons | Rockville | Maryland | 20852 | — |
| Arcturus Healthcare, PLC. | Troy | Michigan | 48098 | — |
| Diabetes & Endo Specialists Inc | Chesterfield | Missouri | 63017 | — |
| Methodist Phys. Clinic | Omaha | Nebraska | 68114 | — |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198-3020 | — |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89128 | — |
| Southern NH Diabetes and Endo_Nashua | Nashua | New Hampshire | 03060 | — |
| Albuquerque Clin Trials, Inc. | Albuquerque | New Mexico | 87102 | — |
| N.Y. Total Medical Care PC | Brooklyn | New York | 11215 | — |
| Northwell Health Div of Endo | Great Neck | New York | 11021 | — |
| NYU Grossman School of Med | New York | New York | 10016 | — |
| Endocrine Associates of Long Island, PC | Smithtown | New York | 11787 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| University of North Carolina | Chapel Hill | North Carolina | 27514 | — |
| Physicians East Endocrinology | Greenville | North Carolina | 27834 | — |
| Medication Management, LLC | Raleigh | North Carolina | 27609 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| Ardmore Family Practice | Winston-Salem | North Carolina | 27103 | — |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | — |
| Plains Clinical Research Center, LLC | Fargo | North Dakota | 58104 | — |
| Diab & Endo Assoc of Stark Co | Canton | Ohio | 44718 | — |
| Providence Health Partners Ctr | Dayton | Ohio | 45439 | — |
| Prestige Clinical Research | Franklin | Ohio | 45005 | — |
| Your Diabetes Endocrine Nutrition Group, Inc. | Mentor | Ohio | 44060 | — |
| Clinical Research Source Inc | Perrysburg | Ohio | 43551 | — |
| Intend Research | Norman | Oklahoma | 73069 | — |
| Oregon Health & Science University_Portland | Portland | Oregon | 97239-3098 | — |
| Heritage Valley Medical Group Inc | Beaver | Pennsylvania | 15009 | — |
| Indiana-Armstrong Endocrinology Associates | Indiana | Pennsylvania | 15701 | — |
| The Diabetes Center, LLC | Murrells Inlet | South Carolina | 29576 | — |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681-1538 | — |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Texas Diab & Endo, P.A. | Austin | Texas | 78731 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | — |
| PrimeCare Medical Group | Houston | Texas | 77024 | — |
| JCCT- Juno NW Houston | Houston | Texas | 77040 | — |
| Fmc Science, Llc | Lampasas | Texas | 76550 | — |
| Texas Diab & Endo, P.A. | Round Rock | Texas | 78681 | — |
| Clinical Trials of Texas, LLC | San Antonio | Texas | 78229 | — |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | — |
| Simcare Medical Research, LLC | Sugar Land | Texas | 77478 | — |
| Elite Medical Care | Sugar Land | Texas | 77479 | — |
| Wade Family Medicine | Bountiful | Utah | 84010 | — |
| Advanced Research Institute | Ogden | Utah | 84405 | — |
| Chrysalis Clinical Research | St. George | Utah | 84790 | — |
| Danville Internal Medicine Inc | Danville | Virginia | 24541-2834 | — |
| TPMG Clinical Research | Newport News | Virginia | 23606 | — |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | — |
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 101 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04460885, 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 4, 2025 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04460885 live on ClinicalTrials.gov.