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Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (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: May 15, 2017
Last verified: May 2017
August 6, 2010
May 15, 2017
August 31, 2010
December 17, 2015   (Final data collection date for primary outcome measure)
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.
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 ]
Complete list of historical versions of study NCT01179048 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
A Long-term, Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
  • Diabetes
  • Diabetes Mellitus, Type 2
  • 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
  • Experimental: Liraglutide
    Intervention: Drug: liraglutide
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9340
December 17, 2015
December 17, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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
Czech Republic
 
NCT01179048
EX2211-3748
2009-012201-19 ( EudraCT Number )
U1111-1113-7090 ( Other Identifier: WHO )
CTR20130003 ( Other Identifier: CFDA )
Yes
Not Provided
Not Provided
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
May 2017

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