A Research Study to Compare Two Types of Insulin, a New Weekly Insulin, Insulin Icodec and an Available Daily Insulin, Insulin Glargine, Both in Combination With Mealtime Insulin, in People With Type 2 Diabetes Who Use Daily Insulin and Mealtime Insulin (ONWARDS 4)
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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT04880850. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.
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Official title
A 26-week Trial Comparing the Effect and Safety of Once Weekly Insulin Icodec and Once Daily Insulin Glargine 100 Units/mL, Both in Combination With Bolus Insulin With or Without Non-insulin Anti-diabetic Drugs, in Subjects With Type 2 Diabetes on a Basal-bolus Regimen
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 will get is decided by chance. Participants will also get a mealtime insulin.The insulin is injected with a needle in a skin fold in the thigh, upper arm or stomach. The study will last for about 8 months. participants will have 17 clinic visits and 13 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. Participants will be asked to wear a sensor that measures their blood sugar all the time in 3 periods for a total of 13 weeks (about 3 months) during the study. Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Study identification
- NCT ID
- NCT04880850
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 582 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- 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 14, 2021 (Actual)
- Primary completion
- Jun 16, 2022 (Actual)
- Completion
- Jun 16, 2022 (Actual)
- Last update posted
- Dec 4, 2025
2021 – 2022
United States locations
- U.S. sites
- 52
- U.S. states
- 23
- U.S. cities
- 47
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lynn Institute of the Ozarks | Little Rock | Arkansas | 72204 | — |
| Anaheim Clinical Trials | Anaheim | California | 92801 | — |
| John Muir Physicians Network | Concord | California | 94520 | — |
| Valley Research | Fresno | California | 93720 | — |
| Diabetes/Lipid Mgmt & Res Ctr | Huntington Beach | California | 92648 | — |
| Valley Clinical Trials, Inc. | Northridge | California | 91325 | — |
| Clinical Trials Research_Sacramento_0 | Sacramento | California | 95821 | — |
| Diabetes Research Center | Tustin | California | 92780 | — |
| Coastal Metabolic Research Center | Ventura | California | 93003 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Chase Medical Research LLC | Waterbury | Connecticut | 06708 | — |
| MedStar Diabetes Institute | Washington D.C. | District of Columbia | 20010 | — |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | — |
| Clinical Trial Res Assoc,Inc | Plantation | Florida | 33324 | — |
| Metabolic Research Institute Inc | West Palm Beach | Florida | 33401 | — |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| East West Med Res Inst | Honolulu | Hawaii | 96814 | — |
| Saltzer Medical Group Research | Nampa | Idaho | 83686-6011 | — |
| Velocity Clin. Res Valparaiso | Valparaiso | Indiana | 46383 | — |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | — |
| Jefferson City Medical Group, PC | Jefferson City | Missouri | 65109 | — |
| VA NEB - Western IA Health Stm | Omaha | Nebraska | 68105 | — |
| Methodist Physicians Clin | Omaha | Nebraska | 68114 | — |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89148 | — |
| AMC Community Endocrinology | Albany | New York | 12206 | — |
| Northport VA Medical Center_Northport_0 | Northport | New York | 11768 | — |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | — |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | — |
| Mountain Diabetes & Endocrine Center | Asheville | North Carolina | 28803 | — |
| Physician's East Endocrinology | Greenville | North Carolina | 27834 | — |
| Your Diabetes Endocrine Nutrition Group, Inc. | Mentor | Ohio | 44060 | — |
| Oregon Health & Science University_Portland_0 | Portland | Oregon | 97239 | — |
| Indiana-Armstrong Endocrinology Associates | Indiana | Pennsylvania | 15701 | — |
| Prisma Health-Upstate | Greenville | South Carolina | 29605-4254 | — |
| AM Diabetes And Endocrinology Center | Bartlett | Tennessee | 38133 | — |
| WR-ClinSearch, LLC | Chattanooga | Tennessee | 37421 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Vanderbilt Diab Obes Clin Tri | Nashville | Tennessee | 37212 | — |
| 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 PA | Corpus Christi | Texas | 78414 | — |
| Baylr Sctt White Rs Inst, Endo | Dallas | Texas | 75226 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| UT Southwestern Med Cntr | Dallas | Texas | 75390-9302 | — |
| Protenium Clinical Research_Hurst | Fort Worth | Texas | 76113 | — |
| DCOL Ctr for Clin Res | Longview | Texas | 75605 | — |
| Capital Clin Res Ctr,LLC | Olympia | Washington | 98502 | — |
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 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04880850, 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 Nov 15, 2026
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