Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results

Study ID
STU 072010-150

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern-Clinical Translational Research Center (CTRC)
  • Parkland Health & Hospital System

Contact
Laura Golici
214-648-2515
laura.golici@utsouthwestern.edu

Principal Investigator
Ildiko Lingvay

Summary

a long term multi centre, international, randomised double- blind placebo- controlled trial of comparasion of liraglutide or placebo in addition to the care of subjects that will otherwise be decided by the subject's physician.

Study Medication/intervention
if the subject decide to participate in this study, the subject will take either:
* Liraglutide 1,8 mg administrated by subcutaneous ( under the skin) injection
* Placebo 1,8 mg administrated by subcutaneous ( under the skin) injection

Participant Eligibility

1. Men or women with type 2 diabetes
2. Age >= 50 years at screening and at least one of the below criteria (from a to h below):
a) prior myocardial infarction
b) prior stroke or prior transient ischaemic attack (TIA)
c) prior coronary, carotid or peripheral arterial revascularisation
d) >50% stenosis on angiography or other imaging of coronary, carotid or lower extremity
arteries
e) history of symptomatic coronary heart disease documented by positive exercise stress test
or any cardiac imaging, or unstable angina with ECG changes
f) asymptomatic cardiac ischemia documented by positive nuclear imaging test or exercise
test or dobutamine stress echo
g) chronic heart failure NYHA class II-III
h) chronic renal failure, having clinically reached a stage corresponding to a glomerular filtration rate < 60 mL/min/1.73m2 per Modification of Diet in Renal Disease (MDRD) or < 60 mL/min per Cockroft-Gault formula
or
Age >= 60 years at screening and meeting at least one of the below criteria (from a to d below)
a) microalbuminuria or proteinuria
b) hypertension and left ventricular hypertrophy by ECG or imaging
c) left ventricular systolic or diastolic dysfunction by imaging
d) ankle/brachial index <0.9
3. Anti-diabetic drug naive or treated with one or more oral anti-diabetic drugs or treated with
human NPH insulin or long-acting insulin analogue,or premixed insulin alone or in combination with OAD(s)
4. HbA1c >= 7.0% at screening
Subjects withdrawn from randomized treatment due to not meeting the age criterion at screening
and thereby violating inclusion criterion 3 can be reintroduced on originally randomized treatment
as each subject reaches the required age. The reintroduction should be planned in relation to a
scheduled visit and there should be no change to the subsequent visit schedule.
2.4