An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin
This trial is active, not recruiting.
|Condition||type 2 diabetes mellitus|
|Sponsor||LG Life Sciences|
|Start date||June 2013|
|End date||December 2017|
|Trial size||5180 participants|
|Trial identifier||NCT02290301, LG-DPOS001|
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 treated with gemigliptin.
Study patients will be followed up to 4 years until MACE occurrence or until the patient drops out of the study or completion of the study. The patient who switches to a non-gemigliptin treatment after initiating gemigliptin therapy will be followed until MACE occurrence or until the patient drops out of the study or completion of the study.
The secondary objectives of the study are to evaluate adverse events related as well as not-related to MACE in diabetic patients treated with gemigliptin.
Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint
time frame: during the study period (2~4 years)
Male or female participants at least 19 years old.
- 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.
- 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
|Official title||An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin|
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