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:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01179048
First received: August 6, 2010
Last updated: February 14, 2013
Last verified: February 2013
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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:
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: | January 2016 |
| Estimated Primary Completion Date: | January 2016 (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 Investigators discretion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01179048
Show 147 Study Locations
Show 147 Study LocationsSponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Christian Gram | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| 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: | February 14, 2013 |
| 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 June 17, 2013