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
- Conditions
- Diabetes Mellitus, Type 1MedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-002374-27-NL
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 580
- Male or female aged 18 years or more at the time of signing informed consent.
- Diagnosed with type 1 diabetes mellitus at least 1 year prior to the day of screening.
- Treated with multiple daily insulin injections (basal and bolus insulin analogue regimes) at least 1 year prior to the day of screening.
- HbA1c below 10% at screening visit based on analysis from central laboratory.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 522
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To confirm the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, in subjects with T1D. 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%.;Secondary Objective: To compare the safety and patient reported outcomes of once weekly insulin icodec versus once daily insulin degludec, both in combination with insulin aspart, in subjects with T1D.;Primary end point(s): 1. Change in HbA1c;Timepoint(s) of evaluation of this end point: 1. From baseline (week 0) to week 26
- Secondary Outcome Measures
Name Time Method