Status:
COMPLETED
Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 31 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2015
Estimated Enrollment :
9341 Patients enrolled
Trial Details
Trial ID
NCT01179048
Start Date
August 31 2010
End Date
December 17 2015
Last Update
July 17 2019
Active Locations (428)
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1
Novo Nordisk Investigational Site
Alabaster, Alabama, United States, 35007
2
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35209
3
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
4
Novo Nordisk Investigational Site
Huntsville, Alabama, United States, 35801