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.

JRCT ID: jRCT2031210031

Registered date:09/04/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: type 1 diabetes
• Date of first enrollment: 30/04/2021
• Target sample size: 80
• Countries of recruitment: Austria,Japan,Canada,Japan,Germany,Japan,India,Japan,Italy,Japan,Netherlands,Japan,Russina Fed.,Japan,Spain,Japan,Trukey,Japan,Unidet Kingdum,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

-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.
-Implementation of blood sampling tests, etc. specified in the protocol.
Etc.

Outcome(s)

• Primary Outcome: 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%.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Oyatani Akihito
• Secondary ID(s): NCT04848480