An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin
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|ClinicalTrials.gov Identifier: NCT02290301|
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : January 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: gemigliptin|
|Study Type :||Observational|
|Actual Enrollment :||5180 participants|
|Official Title:||An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin|
|Actual Study Start Date :||June 28, 2013|
|Actual Primary Completion Date :||November 30, 2017|
|Actual Study Completion Date :||November 30, 2017|
|Type 2 Diabetes Mellitus||
- Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint [ Time Frame: during the study period (2~4 years) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290301
|Korea, Republic of|
|Pusan National University Hospital|
|Busan, Korea, Republic of|