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

Phase 1

• Conditions: Type 2 diabetes mellitus; MedDRA version: 13.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2009-012201-19-GR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-16
• Last Update Posted: 26 September 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8754

Inclusion Criteria

• 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

Exclusion Criteria

• 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 neutral protamine hagedorn (NPH) insulin or long-acting insulin analogue within 3 months prior to screening. Short-term use of other insulin during this period in connection with intercurrent illness is allowed at Investigator’s 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