Clinical trial NCT02290301: An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin
Official title: An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 5180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 5,000 Korean patients whose diabetic condition requires gemigliptin in monotherapy or in combination with other antidiabetic treatment, according to the physician's judgment, will be enrolled.

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint
timeFrame: during the study period (2~4 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
References:
citation: Kim EH, Kim SS, Kim DJ, Choi YS, Lee CW, Ku BJ, Cha KS, Song KH, Kim DK, Kim IJ. A prospective cohort study on effects of gemigliptin on cardiovascular outcomes in patients with type 2 diabetes (OPTIMUS study). Sci Rep. 2020 Nov 4;10(1):19033. doi: 10.1038/s41598-020-75594-5.