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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT01179048

First received: August 6, 2010

Last updated: August 31, 2016

Last verified: August 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

August 6, 2010

Last Updated Date

August 31, 2016

Start Date ^ICMJE

August 2010

Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01179048 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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, hospitalisation for unstable angina or for 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 ]

Original Secondary Outcome Measures ^ICMJE

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 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

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
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

Study Arm (s)

Experimental: Liraglutide
Intervention: Drug: liraglutide
Placebo Comparator: Placebo
Intervention: Drug: placebo

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

9340

Completion Date

December 2015

Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Australia, Austria, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Serbia, South Africa, Spain, Sweden, Taiwan, Turkey, United Arab Emirates, United Kingdom

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01179048

Other Study ID Numbers ^ICMJE

EX2211-3748, 2009-012201-19, U1111-1113-7090, CTR20130003

Has Data Monitoring Committee

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Novo Nordisk A/S

Study Sponsor ^ICMJE

Novo Nordisk A/S

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Global Clinical Registry (GCR, 1452)

Novo Nordisk A/S

Information Provided By

Novo Nordisk A/S

Verification Date

August 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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