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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)
NCT04848480 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG insulin aspart
- DRUG insulin degludec
- DRUG insulin icodec
Study Locations (20)
California
- John Muir Physicians Network — Concord
- Headlands Research California, LLC — Escondido
- Valley Research — Fresno
- Scripps Whittier Diabetes Inst — La Jolla
- Diabetes & Endocrine Associates — La Mesa
- Mills-Peninsula Hlth Services — San Mateo
- Diablo Clinical Research, Inc. — Walnut Creek
Florida
- Northeast Research Institute — Fleming Island
- Center For Diabetes & Endo Care — Fort Lauderdale
- Hanson Clinical Research Center — Port Charlotte
- Northeast Research Institute — Saint Augustine
Colorado
- Barbara Davis Center — Aurora
- Creekside Endocrine Associates, PC — Denver
Georgia
- Physicians Research Assoc. LLC — Lawrenceville
- Endo Res Solutions Inc — Roswell
Illinois
- Northwestern University_Chicago — Chicago
- The University of Chicago — Chicago
Delaware
- Christiana Care Health Services, Inc. — Newark
Kansas
- Cotton-O'Neil Diab & Endo Ctr — Topeka
Maryland
- Endo and Metab Consultants — Rockville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 582 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2022-12-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04848480
The ClinicalTrials.gov registry entry for NCT04848480 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 582 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 189 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions — of which insulin aspart is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04848480 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04848480 about?
NCT04848480 is a clinical study titled "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)". 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 ge...
What is the current status of trial NCT04848480?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 582 participants. The study started on 2021-04-30. Estimated completion is 2022-12-02.
What conditions does trial NCT04848480 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04848480?
The interventions under investigation include: insulin aspart (DRUG), insulin degludec (DRUG), insulin icodec (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04848480?
This trial is sponsored by Novo Nordisk A/S, which has 189 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04848480 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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