EADERLiraglutide Effect and Action in Diabetes:Evaluation of cardiovascular outcome ResultsA Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events - LEADER®
- Conditions
- Type 2 diabetes mellitusMedDRA version: 17.0Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders
- Registration Number
- EUCTR2009-012201-19-DK
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 8754
• Men or women with type 2 diabetes
• Age = 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral vascular disease or chronic renal failure or chronic heart failure OR age = 60 years at screening and other specified risk factors of vascular disease
• HbA1c = 7.0% at screening
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• Type 1 diabetes
• Use of a GLP-1 receptor agonist (exenatide, liraglutide or other) or pramlintide or any (dipeptidyl peptidase 4 (DPP-4) inhibitor within the 3 months prior to screening
•Use of insulin other than human NPH insulin or long-acting insulin analogue or premixed insulin within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed, at Investigators discretion• Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent acute complications of diabetes (e.g., diabetic ketoacidosis) in the previous 3 months
• An acute coronary or cerebrovascular event in the previous 14 days
• Current continuous renal replacement therapy
• End-stage liver disease
• Chronic heart failure NYHA IV
• A prior solid organ transplant or awaiting solid organ transplant
• Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial
medullary thyroid carcinoma (FMTC)
• Personal history of non-familial medullary thyroid carcinoma
• Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy in the previous 5 years. Subjects with intraepithelial squamous cell carcinoma of the skin (Bowen’s disease) treated with topical 5-fluorouracil (5FU) and subjects with basal cell skin cancer are allowed to enter the trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: To assess the efficacy and safety with regard to clinically important events or other surrogate parameters of treatment with liraglutide compared to placebo in adults with type 2 diabetes that are at high risk for cardiovascular events ;Primary end point(s): Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome);Main Objective: To assess the effect of treatment with liraglutide compared to placebo for at least 3.5 year and up to 5 years on the incidence of cardiovascular events, as defined by the below primary and secondary endpoints, in adults with type 2 diabetes that are at high risk for cardiovascular events
- Secondary Outcome Measures
Name Time Method