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NCT04848480 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 3
- Development phase
- 582
- Enrollment target
- 20
- Study locations
NCT04848480: Completed Phase 3 study of Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S.
NCT04848480 is a Phase 3 study of Diabetes Mellitus, Type 1 that has completed, run by Novo Nordisk A/S. The registered enrollment target is 582 participants, below the 1,261-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04848480, a Phase 3 study of Diabetes Mellitus, Type 1, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 582 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Change in HbA1c from baseline to week 26 is presented. Data is reported for 'in-trial' period. In-trial observation period started at randomisation and ended at the date of: the last direct participant-site contact; withdrawal for participants who withdrew their informed consent; the last participant-investigator contact as defined by the investigator for participants who were lost to follow-up (i.e. possibly an unscheduled phone visit); death for participants who died before any of the above.
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 |
What the finished NCT04848480 record still lists
NCT04848480 is an interventional study that assigns participants to a tested intervention. The registered 582 participants enrollment target is mid-sized for trials with a published cap, below the 1,261-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (54% lower).
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.
NCT04848480 names 20 study sites across 8 states, led by California, Florida, Colorado.
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.
What interventions are being tested in trial NCT04848480?
The interventions under investigation include: insulin aspart (DRUG), insulin degludec (DRUG), insulin icodec (DRUG).
Who is sponsoring clinical trial NCT04848480?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04848480's enrollment target sits among peer trials
582 11th of 118 higher than 108 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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