Status:
COMPLETED
An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin
Lead Sponsor:
LG Life Sciences
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19+ years
Brief Summary
The primary objective of the study is to investigate cardiovascular safety of gemigliptin by evaluating the time until patients report with major adverse cardiovascular events (MACE) in T2DM patients ...
Eligibility Criteria
Inclusion
- Female or male patients, who are ≥ 19 years, with diagnosis of T2DM
- Diabetic patients whose condition cannot be adequately controlled by on-going dietary and/or under antidibatetic treatment are decided to prescribe gemigliptin according to the physician's judgment
- Patients must be willing and able to provide written informed consent form to use of personal information as well as the guardian's contact information and the permission to contact with the guardian in case the patient cannot be contacted.
Exclusion
- Patients with T1DM
- Patients who experienced an acute coronary syndrome (ST-elevation myocardial infarction and non- ST elevation myocardial infarction) or ischemic stroke within the last 3 months before enrolment OR patients who have been treated with dipeptidyl peptidase IV (DPP-4) inhibitors or glucagon-like peptide (GLP-1) analogues for 3 months before enrolment.
- Patients with a diagnosis of severe or end-stage heart failure (New York Heart Association class III or IV).
- Patients who are currently participating or plan to participate in any interventional clinical trial
- Patients who are not prescribed gemigliptin or with counterindications for gemigliptin
- Patients who are considered not fit for the study by physician
Key Trial Info
Start Date :
June 28 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
5180 Patients enrolled
Trial Details
Trial ID
NCT02290301
Start Date
June 28 2013
End Date
November 30 2017
Last Update
January 24 2019
Active Locations (1)
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1
Pusan National University Hospital
Busan, South Korea