Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: liraglutide (Drug); placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Stefan Ingelsson, Study Director, Affiliation: Novo Nordisk

Overall contact:
Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

This trial is conducted in Africa, Asia, Europe, and North and South America. The aim of this trial is to determine the long term effect of liraglutide on cardiovascular events in subjects with type 2 diabetes.

Official title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome)

Secondary outcome:

Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, revascularisation, unstable angina or hospitalisation for chronic heart

Time from randomisation to all cause death

Time from randomisation to each individual component of the expanded composite cardiovascular outcome

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or

periphera vascular disease or chronic renal failure or chronic heart failure OR age min. 60 years at screening and other specified risk factors of vascular disease

- HbA1c: 7. 0% or above

- Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs (OADs)

or treated with human NPH insulin or long-acting insulin analogue, alone or in combination with OAD(s)

Exclusion Criteria:

- Type 1 diabetes

- Use of a glucagon-like peptide-1 (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 (trial start)

- Use of insulin other than human NPH insulin or long-acting insulin analogue within

the 3 months prior to screening (trial start). Short-term use of other insulin during this period in connection with intercurrent illness is allowed at the discretion of the Investigors (physicians)

Novo Nordisk Clinical Trial Call Center, Phone: 866-867-7178

Wien 1140, Austria; Recruiting

Leuven 3000, Belgium; Recruiting

Plzen 304 60, Czech Republic; Recruiting

Århus C 8000, Denmark; Recruiting

Kuopio 70210, Finland; Recruiting

Paris 75877, France; Recruiting

Leipzig 04103, Germany; Recruiting

Athens GR-11527, Greece; Recruiting

Bangalore 560 003, India; Recruiting

Dublin 9, Ireland; Recruiting

Jerusalem 91120, Israel; Recruiting

Chieti Scalo 66013, Italy; Recruiting

Seoul 137-701, Korea, Republic of; Recruiting

Durango 34080, Mexico; Recruiting

Nijmegen 6525 GA, Netherlands; Recruiting

Stavanger 4011, Norway; Recruiting

Bialystok 15-435, Poland; Recruiting

Novo Nordisk Clinical Trial Call Center, Caguas 00725, Puerto Rico; Recruiting

Novo Nordisk Clinical Trial Call Center, Toa Baja 00949, Puerto Rico; Recruiting

Craiova 200642, Romania; Recruiting

Barnaul 656045, Russian Federation; Recruiting

Belgrade 11000, Serbia; Recruiting

Móstoles - Madrid - 28935, Spain; Recruiting

Stockholm 141 86, Sweden; Recruiting

Changhua 500, Taiwan; Recruiting

Istanbul 34360, Turkey; Recruiting

Abu Dhabi, United Arab Emirates; Suspended

Dundee DD1 9SY, United Kingdom; Recruiting

Novo Nordisk Clinical Trial Call Center, Birmingham, Alabama 35294, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Birmingham, Alabama 35209, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Fairhope, Alabama 36532, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Hoover, Alabama 35216, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Huntsville, Alabama 35801, United States; Recruiting

Calgary, Alberta T2E 7C5, Canada; Suspended

Novo Nordisk Clinical Trial Call Center, Little Rock, Arkansas 72205-5446, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Little Rock, Arkansas 72205, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Anaheim, California 92801, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cerritos, California 90703-2115, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Chino, California 91710, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Fresno, California 93721-1443, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Los Angeles, California 90017-4006, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Los Banos, California 93635, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Mission Hills, California 91345-1115, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, San Diego, California 92111, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Temecula, California 92591, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Tustin, California 92780, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Walnut Creek, California 94598, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Watsonville, California 95076, United States; Recruiting

Fortaleza, Ceara 60170-001, Brazil; Recruiting

Novo Nordisk Clinical Trial Call Center, Aurora, Colorado 80045-7402, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Denver, Colorado 80220-3808, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Newark, Delaware 19713, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Deland, Florida 32720-0917, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Fort Lauderdale, Florida 33316, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Largo, Florida 33770, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Miami, Florida 33136, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, St. Petersburg, Florida 33701, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33624, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Tampa, Florida 33614-2630, United States; Suspended

Novo Nordisk Clinical Trial Call Center, West Palm Beach, Florida 33409, United States; Recruiting

Johannesburg, Gauteng 1829, South Africa; Recruiting

Novo Nordisk Clinical Trial Call Center, Lawrenceville, Georgia 3004-3388, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Aurora, Illinois 60504, United States; Suspended

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60616, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60612, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Chicago, Illinois 60610-4324, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Crystal Lake, Illinois 60012, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Indianapolis, Indiana 46260-1992, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Michigan City, Indiana 46360, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Iowa City, Iowa 52242, United States; Suspended

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40536, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Lexington, Kentucky 40536-0284, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40206, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Louisville, Kentucky 40202-2043, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Metairie, Louisiana 70006-2930, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Monroe, Louisiana 71203, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, New Orleans, Louisiana 70112, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Baltimore, Maryland 21218-2829, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Baltimore, Maryland 21229, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Bloomfield Hills, Michigan 48302, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Dearborn, Michigan 48124, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Interlochen, Michigan 49643, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Troy, Michigan 48085-5524, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Minneapolis, Minnesota 55416-2699, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Springfield, Missouri 65807, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Great Falls, Montana 59405, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Omaha, Nebraska 68105, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Lebanon, New Hampshire 03756, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Nashua, New Hampshire 03063, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Mine Hill, New Jersey 07803, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Neptune, New Jersey 07753-4859, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Albany, New York 12208, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Buffalo, New York 14221-7091, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, New York, New York 10065, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, New York, New York 10032-3729, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Rochester, New York 14609, United States; Suspended

Novo Nordisk Clinical Trial Call Center, Smithtown, New York 11787, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Syracuse, New York 13210, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Westfield, New York 14787, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Asheville, North Carolina 28803, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Burlington, North Carolina 27215-8700, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Durham, North Carolina 27713, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Greensboro, North Carolina 27455, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Greenville, North Carolina 27834, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Monroe, North Carolina, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Mooresville, North Carolina 28117, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Morehead City, North Carolina 28557, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Whiteville, North Carolina 28472, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45219, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45267, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cincinnati, Ohio 45220-2213, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44106-1716, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Cleveland, Ohio 44106-1702, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Marion, Ohio 43302, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Middleburg Heights, Ohio 44310, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Oklahoma City, Oklahoma 73103, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Oklahoma City, Oklahoma 73104, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Altoona, Pennsylvania 16602-2415, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Beaver, Pennsylvania 15009-1957, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Hatfield, Pennsylvania 19440, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19104-4227, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Philadelphia, Pennsylvania 19107, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Pittsburgh, Pennsylvania 15243, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Uniontown, Pennsylvania 15401-2686, United States; Recruiting

Montreal, Quebec H2W 1R7, Canada; Recruiting

Novo Nordisk Clinical Trial Call Center, Charleston, South Carolina 29425-8900, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Columbia, South Carolina 29203, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Greenville, South Carolina 29605, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Myrtle Beach, South Carolina 29588, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Myrtle Beach, South Carolina 29572-4610, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Bartlett, Tennessee 38133, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Kingsport, Tennessee 37660, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Memphis, Tennessee 38163-0001, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Nashville, Tennessee 37212, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Arlington, Texas 76014, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75246, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75231, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Dallas, Texas 75390-8858, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77095, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Houston, Texas 77070, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Longview, Texas 75605, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Lubbock, Texas 79410, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Odessa, Texas 79761-5100, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, San Antonio, Texas 78217, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Tomball, Texas 77375, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Salt Lake City, Utah 84102, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, South Burlington, Vermont 05403, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Seattle, Washington 98101, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Spokane, Washington 99210, United States; Recruiting

Novo Nordisk Clinical Trial Call Center, Madison, Wisconsin 53717, United States; Recruiting

Clinical Trials at Novo Nordisk

Starting date: August 2010
Last updated: September 29, 2010