Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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 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.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Conditions Studied

Diabetes Mellitus, Type 1

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

FieldValue
Enrollment Target 582 participants
Start Date 2021-04-30
Est. Completion 2022-12-02
Phase Phase 3

Sponsor

Novo Nordisk A/S

431 total trials

Interested in This Trial?

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, categorized as Phase 3. The registered enrollment target is 582 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,261-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (54% lower). The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

Explore more on PlainTrial

Diabetes Mellitus, Type 1

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.