Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
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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: January 7, 2015
Last verified: January 2015
History of Changes

August 6, 2010
January 7, 2015
August 2010
October 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 up to 60 months ] [ Designated as safety issue: No ]
Same as current
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, 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 ]
  • 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 ]
Not Provided
Not Provided
 
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results - A Long Term Evaluation
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Steinberg WM, Nauck MA, Zinman B, Daniels GH, Bergenstal RM, Mann JF, Steen Ravn L, Moses AC, Stockner M, Baeres FM, Marso SP, Buse JB; LEADER Trial investigators. LEADER 3--lipase and amylase activity in subjects with type 2 diabetes: baseline data from over 9000 subjects in the LEADER Trial. Pancreas. 2014 Nov;43(8):1223-31. doi: 10.1097/MPA.0000000000000229.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
9340
October 2015
October 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 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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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
 
NCT01179048
EX2211-3748, 2009-012201-19, U1111-1113-7090
No
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
January 2015

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