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: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002371-17-IT
- 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 Main Objective: The primary objective is to confirm the cardiovascular safety of insulin degludec compared to that of insulin glargine.;Secondary Objective: The secondary objectives are to assess efficacy of insulin degludec on markers of glycaemic control and to assess safety on other parameters in subjects with type 2 diabetes at high risk of cardiovascular events.;Primary end point(s): Time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke<br><br>;Timepoint(s) of evaluation of this end point: From randomisation to 60 months<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Number of severe hypoglycaemic episodes<br>2. Change in Glycosylated haemoglobin (HbA1c)<br>;Timepoint(s) of evaluation of this end point: 1. Week 0 to the last assessment (60 months)<br>2. Week 0 to the last assessment (59 months)<br><br>