A Trial for Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Subjects With Type 2 Diabetes at High Risk of Cardiovascular Events
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Health Condition 2: E11- Type 2 diabetes mellitus
- Registration Number
- CTRI/2014/03/004505
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 357
•Type 2 diabetes
•Age above or equal to 50 years with predefined previous cardiovascular disease(s) or renal disease or age above or equal to 60 years with predefined cardiovascular risk factors
•HbA1c (Glycosylated haemoglobin) above or equal to 7.0% or HbA1c below 7.0% and current insulin treatment corresponding to above or equal to 20 U of basal insulin per day
•One or more oral or injectable antidiabetic agent(s)
50 Years and above
•An acute coronary or cerebrovascular event in the previous 60 days
•Planned coronary, carotid or peripheral artery revascularisation
•Chronic heart failure NYHA (New York Heart Association) 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method