A trial comparing cardiovascular safety of insulin degludec versus insulin glargine in subjects with type 2 diabetes at high risk of cardiovascular events
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 18.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002371-17-PL
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 7500
- Type 2 diabetes
- Age = 50 years with predefined previous cardiovascular disease(s) or renal disease or age = 60 years with predefined cardiovascular risk factors
- HbA1c = 7.0% or HbA1c < 7.0% and current insulin treatment corresponding to = 20 U of basal insulin per day.
- One or more oral or injectable antidiabetic agent(s)
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 2250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5250
- An acute coronary or cerebrovascular event in the previous 60 days
- Planned coronary, carotid or peripheral artery revascularisation
- Chronic heart failure NYHA class IV
- Current or past (within the last 5 years) malignant neoplasms (except basal cell and squamous cell skin carcinoma)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method