Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: August 12, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179048

  Show 138 Study Locations
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: August 12, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
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)
India: Ministry of Health and Family Wellfare
Greece: National Organization for Medicines
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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glucagon-Like Peptide 1
Liraglutide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014