A Research Study to Compare Two Types of Insulin, a New Insulin, Insulin Icodec and an Available Insulin, Insulin Degludec, in People With Type 2 Diabetes Who Have Not Used Insulin Before (ONWARDS 3)
Public ClinicalTrials.gov record NCT04795531. 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 26-week Double Blinded, Multiregional, Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Non-insulin Anti-diabetic Drugs, 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 degludec (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 degludec taken daily. Participants will get their study medicine in an injection pen. Participants will get a pen for weekly injection and one for daily injection. One will be icodec or degludec and the other will be dummy medicine. The treatment participants get is decided by chance. Participants and the study staff will not know which active medicine they get. The insulin is injected with a needle in a skin fold in the thigh. The study could last for about 8 months. Participants will have 13 clinic visits and 17 phone calls with the study doctor. At 8 clinic visits participants will have blood samples taken. At 4 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 become pregnant during the study period.
Study identification
- NCT ID
- NCT04795531
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 588 participants
Conditions and interventions
Conditions
Interventions
- Insulin icodec Drug
- Placebo insulin icodec Drug
- Insulin degludec Drug
- Placebo insulin degludec Drug
Drug
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
- Mar 24, 2021 (Actual)
- Primary completion
- Jun 23, 2022 (Actual)
- Completion
- Jun 23, 2022 (Actual)
- Last update posted
- Jun 12, 2026
2021 – 2022
United States locations
- U.S. sites
- 94
- U.S. states
- 34
- U.S. cities
- 84
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Univ of Alabama Birmingham | Birmingham | Alabama | 35222 | — |
| Lakeview Clinical Research, LLC | Guntersville | Alabama | 35976 | — |
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | — |
| Anaheim Clinical Trials, LLC | Anaheim | California | 92801 | — |
| Advanced Clinical Research/Rancho Paseo Medical Group | Banning | California | 92220 | — |
| American Clinical Trials | Buena Park | California | 90620 | — |
| 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 | San Ramon | California | 94583 | — |
| 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 | — |
| Est Cst Inst for Rsrch,Jksnvil | Jacksonville | Florida | 32216 | — |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | — |
| University Of Miami | Miami | Florida | 33136 | — |
| Suncoast Clinical Research, Inc. | New Port Richey | Florida | 34652 | — |
| Florida Institute for Clinical research | 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 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| RNA America Health Sciences | Sugar Hill | Georgia | 30518 | — |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | — |
| Elite Clinical Trials | Blackfoot | Idaho | 83221 | — |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | — |
| Iowa Diab & Endo Res Center | West Des Moines | Iowa | 50266 | — |
| Cotton-Oneill Diabetes and End | Topeka | Kansas | 66606-2806 | — |
| St Elizabeth Physicians Heart | Covington | Kentucky | 41011 | — |
| Four Rivers Clinical Research Inc | Paducah | Kentucky | 42001 | — |
| MedStar Community Clin Res Ctr | Hyattsville | Maryland | 20782 | — |
| Endo and Metab Consultants | Rockville | Maryland | 20852 | — |
| Arcturus HC PLC Troy Med Res | Troy | Michigan | 48098 | — |
| Diabetes & Endo Specialists Inc | Chesterfield | Missouri | 63017 | — |
| Methodist Physicians Clin | Omaha | Nebraska | 68114 | — |
| 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 | — |
| 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 | 27517 | — |
| Physician's 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 | — |
| Daniel G Williams MD | Perrysburg | Ohio | 43551 | — |
| Intend Research | Norman | Oklahoma | 73069 | — |
| Oregon Health & Science University_Portland_0 | Portland | Oregon | 97239 | — |
| Heritage Valley Multispeciality Group Inc | Beaver | Pennsylvania | 15009 | — |
| 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 | — |
| Spectrum Medical, Inc | Danville | Virginia | 24541 | — |
| TPMG Clinical Research | Newport News | Virginia | 23606 | — |
| Rainier Clin Res Ctr Inc | Renton | Washington | 98057 | — |
| Clinical Investigation Specialists Inc, Kenosha | Kenosha | Wisconsin | 53144 | — |
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 96 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04795531, 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 14, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04795531 live on ClinicalTrials.gov.