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Title   LEADER
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Study Number   EX2211-3748
Other   Quorum Review
Trial Type   Endocrinology
Condition   Type 2 Diabetes
Specifics   Type 2 Diabetes
Trial Status   Open to Accrual
Principal Investigator   Philip A. Levin¸ MD
Contact Name   Ranessa Labovitz
Phone   (410) 583-2471
Description   A Long Term Multi-centre, International, Randomised Double-blind, Placebo-controlled Trial to Determine Liraglutide Effects on Cardiovascular Events


Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No


Inclusion Criteria:

  • Type 2 diabetes
  • Age min. 50 years at screening and concomitant cardiovascular, cerebrovascular or periphera 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, 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 within the 3 months prior to screening (trial start). Short-term use of other insulin during this period in connection with intercurrent illness is allowed at the discretion of the Investigors (physicians)
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