Research study comparing a new medicine fast-acting insulin aspart to another already available medicine NovoRapid® in people with type 2 diabetes

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 20.0 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000072461; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2016-000878-38-CZ
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-07-03
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 1262

Inclusion Criteria

- Male or female, age = 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes = 10 years prior to screening (Visit 1).
- Treated with a basal-bolus insulin regimen = 365 days prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen.
- Treated with or without oral antidiabetic drugs including extended release formulations. If treated with metformin, the total daily prescribed dose must have been stable for at least 90 days prior to screening (Visit 1).
- HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).

Randomisation criterion:
- HbA1c = 9.0% measured by the central laboratory at Visit 13 (week -1).
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 965
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 107

Exclusion Criteria

- Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1).
- Subjects presently classified as being in New York Heart Association (NYHA) Class IV.
- Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1).
- Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1).
- 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified