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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01179048
First received: August 6, 2010
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) [ Time Frame: from randomisation up to 60 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time from rand. 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 failure [ Time Frame: from randomisation up to 60 months ] [ Designated as safety issue: No ]
  • Time from randomisation to all cause death [ Time Frame: from randomisation up to 60 months ] [ Designated as safety issue: No ]
  • Time from randomisation to each individual component of the expanded composite cardiovascular outcome [ Time Frame: from randomisation up to 60 months ] [ Designated as safety issue: No ]

Enrollment: 9340
Study Start Date: August 2010
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liraglutide Drug: liraglutide
Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
Placebo Comparator: Placebo Drug: placebo
Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or peripheral 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 or premixed insulin, 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 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 Investigator's discretion
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179048

  Hide Study Locations
Locations
United States, Alabama
Novo Nordisk Clinical Trial Call Center
Alabaster, Alabama, United States, 35007
Novo Nordisk Clinical Trial Call Center
Birmingham, Alabama, United States, 35209
Novo Nordisk Clinical Trial Call Center
Fairhope, Alabama, United States, 36532
United States, Arizona
Novo Nordisk Clinical Trial Call Center
Tempe, Arizona, United States, 85283
United States, Arkansas
Novo Nordisk Clinical Trial Call Center
Little Rock, Arkansas, United States, 72205
United States, California
Novo Nordisk Clinical Trial Call Center
Anaheim, California, United States, 92801
Novo Nordisk Clinical Trial Call Center
Cerritos, California, United States, 90703-2115
Novo Nordisk Clinical Trial Call Center
Chino, California, United States, 91710
Novo Nordisk Clinical Trial Call Center
Escondido, California, United States, 92026
Novo Nordisk Clinical Trial Call Center
Fresno, California, United States, 93721-1443
Novo Nordisk Clinical Trial Call Center
Los Angeles, California, United States, 90017-4006
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Los Banos, California, United States, 93635
Novo Nordisk Clinical Trial Call Center
Mission Hills, California, United States, 91345
Novo Nordisk Clinical Trial Call Center
San Diego, California, United States, 92111
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Tustin, California, United States, 92780
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Walnut Creek, California, United States, 94598
Novo Nordisk Clinical Trial Call Center
Watsonville, California, United States, 95076
United States, Colorado
Novo Nordisk Clinical Trial Call Center
Aurora, Colorado, United States, 80045-7402
Novo Nordisk Clinical Trial Call Center
Denver, Colorado, United States, 80220-3808
United States, Delaware
Novo Nordisk Clinical Trial Call Center
Newark, Delaware, United States, 19713
United States, Florida
Novo Nordisk Clinical Trial Call Center
Bradenton, Florida, United States, 34208
Novo Nordisk Clinical Trial Call Center
Clearwater, Florida, United States, 33756
Novo Nordisk Clinical Trial Call Center
Deland, Florida, United States, 32720-0917
Novo Nordisk Clinical Trial Call Center
Fort Lauderdale, Florida, United States, 33316
Novo Nordisk Clinical Trial Call Center
Kissimmee, Florida, United States, 34741
Novo Nordisk Clinical Trial Call Center
Miami, Florida, United States, 33136
Novo Nordisk Clinical Trial Call Center
Orlando, Florida, United States, 32804
Novo Nordisk Clinical Trial Call Center
St. Petersburg, Florida, United States, 33711
Novo Nordisk Clinical Trial Call Center
Tampa, Florida, United States, 34677
United States, Georgia
Novo Nordisk Clinical Trial Call Center
Lawrenceville, Georgia, United States, 30046
Novo Nordisk Clinical Trial Call Center
Roswell, Georgia, United States, 30076
United States, Illinois
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60612
Novo Nordisk Clinical Trial Call Center
Chicago, Illinois, United States, 60616
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Chicago, Illinois, United States, 60654
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Crystal Lake, Illinois, United States, 60012
United States, Indiana
Novo Nordisk Clinical Trial Call Center
Michigan City, Indiana, United States, 46360
United States, Kentucky
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40206
Novo Nordisk Clinical Trial Call Center
Louisville, Kentucky, United States, 40202-2043
United States, Louisiana
Novo Nordisk Clinical Trial Call Center
Metairie, Louisiana, United States, 70006-2930
Novo Nordisk Clinical Trial Call Center
Monroe, Louisiana, United States, 71203
Novo Nordisk Clinical Trial Call Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21218-2829
Novo Nordisk Clinical Trial Call Center
Baltimore, Maryland, United States, 21204
United States, Michigan
Novo Nordisk Clinical Trial Call Center
Bloomfield Hills, Michigan, United States, 48302
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Dearborn, Michigan, United States, 48124
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Interlochen, Michigan, United States, 49643
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Troy, Michigan, United States, 48085-5524
United States, Minnesota
Novo Nordisk Clinical Trial Call Center
Minneapolis, Minnesota, United States, 55416-2699
United States, Missouri
Novo Nordisk Clinical Trial Call Center
Springfield, Missouri, United States, 65807
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St. Louis, Missouri, United States, 63108
United States, Montana
Novo Nordisk Clinical Trial Call Center
Great Falls, Montana, United States, 59405
United States, Nebraska
Novo Nordisk Clinical Trial Call Center
Omaha, Nebraska, United States, 68105
United States, New Hampshire
Novo Nordisk Clinical Trial Call Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Novo Nordisk Clinical Trial Call Center
Mine Hill, New Jersey, United States, 07803
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Neptune, New Jersey, United States, 07753-4859
United States, New York
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Albany, New York, United States, 12208
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New York, New York, United States, 10032-3729
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New York, New York, United States, 10065
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Smithtown, New York, United States, 11787
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Syracuse, New York, United States, 13210
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Westfield, New York, United States, 14787
United States, North Carolina
Novo Nordisk Clinical Trial Call Center
Asheville, North Carolina, United States, 28803
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Burlington, North Carolina, United States, 27215-8700
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Durham, North Carolina, United States, 27713
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Greensboro, North Carolina, United States, 27401
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Greenville, North Carolina, United States, 27834
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Monroe, North Carolina, United States, 28204
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Mooresville, North Carolina, United States, 28117
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Morehead City, North Carolina, United States, 28557
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Whiteville, North Carolina, United States, 28472
United States, Ohio
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Cincinnati, Ohio, United States, 45219
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Cleveland, Ohio, United States, 44106-1702
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Marion, Ohio, United States, 43302
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Middleburg Heights, Ohio, United States, 44310
United States, Oklahoma
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73104
Novo Nordisk Clinical Trial Call Center
Oklahoma City, Oklahoma, United States, 73103
United States, Pennsylvania
Novo Nordisk Clinical Trial Call Center
Altoona, Pennsylvania, United States, 16602-2415
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Philadelphia, Pennsylvania, United States, 19104-4227
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Philadelphia, Pennsylvania, United States, 19107
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Pittsburgh, Pennsylvania, United States, 15243
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Uniontown, Pennsylvania, United States, 15401-2686
United States, South Carolina
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Charleston, South Carolina, United States, 29425-6240
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Columbia, South Carolina, United States, 29203
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Greenville, South Carolina, United States, 29607
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Greer, South Carolina, United States, 29651
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Murrells Inlet, South Carolina, United States, 29576
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Myrtle Beach, South Carolina, United States, 29572-4610
United States, Tennessee
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Bartlett, Tennessee, United States, 38133
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Johnson City, Tennessee, United States, 37604
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Memphis, Tennessee, United States, 38163-0001
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Nashville, Tennessee, United States, 37212
United States, Texas
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Arlington, Texas, United States, 76014
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Dallas, Texas, United States, 75230
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Dallas, Texas, United States, 75246
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Dallas, Texas, United States, 75390-8858
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Dallas, Texas, United States, 75231
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Houston, Texas, United States, 77095
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Houston, Texas, United States, 77070
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Longview, Texas, United States, 75605
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Odessa, Texas, United States, 79761-5100
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Schertz, Texas, United States, 78154
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Tomball, Texas, United States, 77375
United States, Utah
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Salt Lake City, Utah, United States, 84102
United States, Washington
Novo Nordisk Clinical Trial Call Center
Spokane, Washington, United States, 99202
United States, Wisconsin
Novo Nordisk Clinical Trial Call Center
Madison, Wisconsin, United States, 53792
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Austria
Wien, Austria, 1140
Belgium
Leuven, Belgium, 3000
Brazil
Fortaleza, Ceara, Brazil, 60170-001
Canada, Quebec
Montreal, Quebec, Canada, H2W 1R7
China, Beijing
Beijing, Beijing, China, 100853
Czech Republic
Plzen, Czech Republic, 304 60
Denmark
Århus C, Denmark, 8000
Finland
Kuopio, Finland, 70210
France
Paris, France, 75877
Germany
Leipzig, Germany, 04103
Greece
Athens, Greece, GR-11527
India
Bangalore, Karnataka, India, 560 003
Ireland
Dublin 9, Ireland
Israel
Jerusalem, Israel, 91240
Italy
Chieti Scalo, Italy, 66100
Korea, Republic of
Seoul, Korea, Republic of, 137-701
Mexico
Durango, Mexico, 34080
Netherlands
Groningen, Netherlands, 9728 NT
Norway
Stavanger, Norway, 4011
Poland
Bialystok, Poland, 15-435
Puerto Rico
Novo Nordisk Clinical Trial Call Center
Bayamon, Puerto Rico, 00961
Novo Nordisk Clinical Trial Call Center
Caguas, Puerto Rico, 00725
Romania
Craiova, Dolj, Romania, 200642
Russian Federation
Barnaul, Russian Federation, 656045
Serbia
Belgrade, Serbia, 11000
South Africa
Johannesburg, Gauteng, South Africa, 1829
Spain
Mostoles - Madrid -, Spain, 28935
Sweden
Stockholm, Sweden, 141 86
Taiwan
Changhua, Taiwan, 500
Turkey
Istanbul, Turkey, 34360
United Arab Emirates
Dubai, United Arab Emirates, 4545
United Kingdom
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01179048     History of Changes
Other Study ID Numbers: EX2211-3748, 2009-012201-19, U1111-1113-7090
Study First Received: August 6, 2010
Last Updated: March 10, 2014
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Brazil: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medicinal Devices (BfarM)
Greece: National Organization for Medicines
India: Ministry of Health and Family Wellfare
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: Ministry of Health
South Korea: Korea Food and Drug Administration (KFDA)
Mexico: COFEPRIS Federal Comission for the Protection of Sanitary Risks
Netherlands: Medicines Evaluation Board
Norway: Norwegian Medicines Agency
Poland: National Medicines Institute
Romania: National Medicines Agency
Russia: Fed. State Entity Sci. Centre of Medicinal Products Expertise
Serbia: Medicines and Medical Devices Agency of Serbia
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Turkey: Ministry of Health
United Arab Emirates: Ministry of Health
United Kingdom: Medicines and Healthcare Regulatory Authority (MHRA)
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014