A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin degludec, in people with type 2 diabetes who use daily insuli

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-000454-10-DE
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2D at least 180 days prior to the day of screening.
- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Treated with once daily or twice daily basal insulin (Neutral Protamine Hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL): at least 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses at least 90 days prior to screening:
- Metformin
- Sulfonylureas
- Meglitinides (glinides)
- Dipeptidyl peptidase-4 (DPP-4) inhibitors
- Sodium-glucose Co-transporter-2 (SGLT2) inhibitors
- Thiazolidinediones
- Alpha-glucosidase inhibitors
- Oral combination products (for the allowed individual oral anti-diabetic drugs)
- Oral or injectable glucagon like peptides 1 (GLP-1)-receptor agonists
- Body mass index (BMI) equal to or below 40.0 kg/m^2
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 312
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 208

Exclusion Criteria

- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association 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