Status:
COMPLETED
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)
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 take...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2022
Estimated Enrollment :
582 Patients enrolled
Trial Details
Trial ID
NCT04848480
Start Date
April 30 2021
End Date
December 2 2022
Last Update
December 4 2025
Active Locations (130)
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1
John Muir Physicians Network
Concord, California, United States, 94520
2
Headlands Research California, LLC
Escondido, California, United States, 92025
3
Valley Research
Fresno, California, United States, 93720
4
Scripps Whittier Diabetes Inst
La Jolla, California, United States, 92037