A Research Study to Compare a New Weekly Insulin, Insulin Icodec, and an Available Daily Insulin, Insulin Degludec, Both in Combination With Mealtime Insulin in People With Type 1 Diabetes (ONWARDS 6)
Public ClinicalTrials.gov record NCT04848480. 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
Efficacy and Safety of Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec 100 Units/mL, Both in Combination With Insulin Aspart, in Adults With Type 1 Diabetes. A 26-week, Randomised, Multicentre, Open-label, Active-controlled, Parallel Group, Two Armed, Treat-to-target Trial Investigating the Effect on Glycaemic Control and Safety of Treatment With Once Weekly Insulin Icodec Compared to Once Daily Insulin Degludec, Both in Combination With Insulin Aspart in Adults With Type 1 Diabetes, With a 26-week Extension Investigating Long Term Safety
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study compares insulin icodec (a new insulin) to insulin degludec (an insulin already available on the market) in people with type 1 diabetes. The study will look at how well insulin icodec taken weekly controls blood sugar compared to insulin degludec 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 degludec that participants will have to inject once a day at the same time every day. Which treatment participants get is decided at random. 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 1 year and 2 months. Participants will have 28 clinic visits and 28 phone calls with the study doctor. At 11 clinic visits participants will have blood samples taken. At 6 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 your blood sugar all the time. Participants will be asked to wear it for a total of 57 weeks (around 1 year). Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.
Study identification
- NCT ID
- NCT04848480
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 582 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 29, 2021
- Primary completion
- Apr 27, 2022
- Completion
- Dec 1, 2022
- Last update posted
- Dec 3, 2025
2021 – 2022
United States locations
- U.S. sites
- 42
- U.S. states
- 21
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| John Muir Physicians Network | Concord | California | 94520 | — |
| Headlands Research California, LLC | Escondido | California | 92025 | — |
| Valley Research | Fresno | California | 93720 | — |
| Scripps Whittier Diabetes Inst | La Jolla | California | 92037 | — |
| Diabetes & Endocrine Associates | La Mesa | California | 91942 | — |
| Mills-Peninsula Hlth Services | San Mateo | California | 94401 | — |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | — |
| Barbara Davis Center | Aurora | Colorado | 80045 | — |
| Creekside Endocrine Associates, PC | Denver | Colorado | 80246 | — |
| Christiana Care Health Services, Inc. | Newark | Delaware | 19713 | — |
| Northeast Research Institute | Fleming Island | Florida | 32003 | — |
| Center For Diabetes & Endo Care | Fort Lauderdale | Florida | 33312 | — |
| Hanson Clinical Research Center | Port Charlotte | Florida | 33952 | — |
| Northeast Research Institute | Saint Augustine | Florida | 32080 | — |
| Physicians Research Assoc. LLC | Lawrenceville | Georgia | 30046 | — |
| Endo Res Solutions Inc | Roswell | Georgia | 30076 | — |
| Northwestern University_Chicago | Chicago | Illinois | 60611 | — |
| The University of Chicago | Chicago | Illinois | 60637 | — |
| Cotton-O'Neil Diab & Endo Ctr | Topeka | Kansas | 66606 | — |
| Endo and Metab Consultants | Rockville | Maryland | 20852 | — |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | — |
| MassResearch, LLC | Waltham | Massachusetts | 02453 | — |
| Minn Center For Obesity Met & Endocrinology | Eagan | Minnesota | 55123 | — |
| International Diabetes Center | Minneapolis | Minnesota | 55416 | — |
| Jefferson City Medical Group, PC | Jefferson City | Missouri | 65109 | — |
| Mercy Research | Springfield | Missouri | 65807 | — |
| Methodist Physicians Clin | Omaha | Nebraska | 68114 | — |
| Palm Research Center Inc-Vegas | Las Vegas | Nevada | 89128 | — |
| Southern NH Diabetes and Endo_Nashua | Nashua | New Hampshire | 03060 | — |
| John J Shelmet, MD | Lawrenceville | New Jersey | 08648 | — |
| AMC Community Endocrinology | Albany | New York | 12203 | — |
| Accellacare | Wilmington | North Carolina | 28401 | — |
| Prisma Health-Upstate | Greenville | South Carolina | 29605-4254 | — |
| Univ Diab & Endo Consultants | Chattanooga | Tennessee | 37411 | — |
| Amarillo Med Spec LLP | Amarillo | Texas | 79106 | — |
| Texas Diab & Endo, P.A. | Austin | Texas | 78731 | — |
| Texas Diab & Endo, P.A. | Austin | Texas | 78749 | — |
| Velocity Clinical Res-Dallas | Dallas | Texas | 75230 | — |
| North Texas Endocrine Center | Dallas | Texas | 75231 | — |
| PlanIt Research, PLLC | Houston | Texas | 77079 | — |
| NE Clin Res of San Antonio | San Antonio | Texas | 78233 | — |
| 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 88 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04848480, 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 NCT04848480 live on ClinicalTrials.gov.