Efficacy and safety of once weekly insulin icodec compared to once daily insulin degludec 100 units/mL, both in combination with insulin aspart, in adults with type 1 diabetes.

Efficacy and safety of once weekly insulin icodec compared to once daily insulin degludec 100 units/mL, both in combination with insulin aspart, in adults with type 1 diabetes.(NN1436-4625) - ONWARDS6

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210031

Enrollment

Registered

2021-04-09

Start date

2021-04-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 1 diabetes

Interventions

-Two arm for insulin icodec and insulin degludec -Use insulin aspart as a concomitant medication -The study will consist of 3 periods: a Screening Period, a Treatment Period, and a Follow-Up Period. -

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Male or female aged >=18 years at the time of signing informed consent. 2.Diagnosed with type 1 diabetes mellitus>=1 year prior to the day of screening. 3.Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) >= 1 year prior to the day of screening. 4.HbA1c <10% at screening visit based on analysis from central laboratory.

Exclusion criteria

Exclusion criteria: 1.Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening. 2.Chronic heart failure classified as New York Heart Association (NYHA) Class IV at screening. 3.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). 4.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.

Design outcomes

Primary

Measure	Time frame
To confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with type 1 diabetes. This includes comparing the difference in change from baseline in HbA1c between once weekly insulin icodec and once daily insulin degludec both in combination with insulin aspart after 26 weeks of treatment to a non-inferiority limit of 0.3%.	—

Countries

Austria, Canada, Germany, India, Italy, Japan, Netherlands, Russina Fed., Spain, Trukey, Unidet Kingdum, United States

Contacts

Public ContactAkihito Oyatani

Novo Nordisk Pharma Ltd.

JPHC_clinical_trials@novonordisk.com+81-362661000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026