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)
Completed · Phase 3
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT04848480
- Run by
- Novo Nordisk A/S
- People needed
- 582
- Starts
- 2021-04-30
- Expected to finish
- 2022-12-02
- Last updated by the study team
- 2025-12-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female aged greater than or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus greater than or equal to 1 year prior to the day of screening.
- Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) greater than or equal to 1 year prior to the day of screening.
- HbA1c below10% at screening visit based on analysis from central laboratory.
You may not qualify if…
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Where it is running
- Headlands Research California, LLC — Escondido, California, United States
- Valley Research — Fresno, California, United States
- Scripps Whittier Diabetes Inst — La Jolla, California, United States
- Diabetes & Endocrine Associates — La Mesa, California, United States
- Mills-Peninsula Hlth Services — San Mateo, California, United States
- Diablo Clinical Research, Inc. — Walnut Creek, California, United States
- Barbara Davis Center — Aurora, Colorado, United States
- Creekside Endocrine Associates, PC — Denver, Colorado, United States
- Christiana Care Health Services, Inc. — Newark, Delaware, United States
- Northeast Research Institute — Fleming Island, Florida, United States
- Center For Diabetes & Endo Care — Fort Lauderdale, Florida, United States
- Hanson Clinical Research Center — Port Charlotte, Florida, United States
- Northeast Research Institute — Saint Augustine, Florida, United States
- Physicians Research Assoc. LLC — Lawrenceville, Georgia, United States
- Endo Res Solutions Inc — Roswell, Georgia, United States
- Northwestern University_Chicago — Chicago, Illinois, United States
- The University of Chicago — Chicago, Illinois, United States
- Cotton-O'Neil Diab & Endo Ctr — Topeka, Kansas, United States
- Endo and Metab Consultants — Rockville, Maryland, United States
- Brigham & Women's Hospital — Boston, Massachusetts, United States
- MassResearch, LLC — Waltham, Massachusetts, United States
- Minn Center For Obesity Met & Endocrinology — Eagan, Minnesota, United States
- International Diabetes Center — Minneapolis, Minnesota, United States
- Jefferson City Medical Group, PC — Jefferson City, Missouri, United States
- John Muir Physicians Network — Concord, California, United States
Full record on ClinicalTrials.gov
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