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

Phase 1

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 1; MedDRA version: 21.1Level: LLTClassification code 10045228Term: Type I diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-002374-27-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-28
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

- 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

Exclusion Criteria

- 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