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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01179048
Recruitment Status : Completed
First Posted : August 10, 2010
Results First Posted : March 1, 2017
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE August 6, 2010
First Posted Date  ICMJE August 10, 2010
Results First Submitted Date  ICMJE December 16, 2016
Results First Posted Date  ICMJE March 1, 2017
Last Update Posted Date July 17, 2019
Actual Study Start Date  ICMJE August 31, 2010
Actual Primary Completion Date December 17, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
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 (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
Time from randomisation to first occurrence of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome). The percentage of subjects experiencing a first event of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke (a composite cardiovascular outcome) is presented.
Original Primary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2017)
  • 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 (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
    Time from randomisation to first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure. The percentage of subjects experiencing first occurrence of an expanded composite cardiovascular outcome defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or for heart failure is presented.
  • Time From Randomisation to All Cause Death [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
    Time from randomisation to all cause death. The percentage of subjects with a death by any cause (all-cause death) is presented.
  • Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
    Time from randomisation to each individual component of the expanded composite cardiovascular outcome. The percentage of subjects experiencing each of the individual component of the expanded composite cardiovascular outcome (defined as either cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularisation, hospitalisation for unstable angina or heart failure) is presented.
  • Time From Randomisation to First Occurrence of a Composite Microvascular Outcome [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
    Time from randomisation to first occurrence of a composite microvascular outcome, defined as any one of the following:
    • new onset of persistent macroalbuminuria
    • persistent doubling of serum creatinine
    • need for continuous renal replacement therapy
    • death due to renal disease
    • need for retinal photocoagulation or treatment with intravitreal agents
    • vitreous haemorrhage
    • diabetes-related blindness
    The percentage of subjects experiencing a first occurrence of a composite microvascular outcome is presented.
  • Time From Randomisation to Each Individual Component of the Composite Microvascular Outcome and to the Retinopathy and Nephropathy Composite Outcomes Separately. [ Time Frame: from randomisation (visit 3; month 0) to last contact (visit 16; up to month 60+30 days) ]
    Time from randomisation to each individual component of the composite microvascular outcome and to the retinopathy and nephropathy composite outcomes separately. The percentage of subjects experiencing each individual component of the composite microvascular outcome are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2010)
  • 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 ]
  • Time From Randomisation to All Cause Death [ Time Frame: from randomisation up to 60 months ]
  • Time From Randomisation to Each Individual Component of the Expanded Composite Cardiovascular Outcome [ Time Frame: from randomisation up to 60 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
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  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Arms  ICMJE
  • 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
Actual Enrollment  ICMJE
 (submitted: May 28, 2019)
9341
Original Estimated Enrollment  ICMJE
 (submitted: August 9, 2010)
8754
Actual Study Completion Date  ICMJE December 17, 2015
Actual Primary Completion Date December 17, 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 cardiovascular 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czechia,   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,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01179048
Other Study ID Numbers  ICMJE EX2211-3748
2009-012201-19 ( EudraCT Number )
U1111-1113-7090 ( Other Identifier: WHO )
CTR20130003 ( Other Identifier: CFDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE 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
PRS Account Novo Nordisk A/S
Verification Date July 2019

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