An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated With Gemigliptin

LG Life Sciences

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: gemigliptin

Study type: Observational

Funder types: Industry

Identifiers

NCT02290301

LG-DPOS001

Details and patient eligibility

About

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.

Enrollment: 5,180 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

5,180 participants in 1 patient group

Type 2 Diabetes Mellitus

Treatment:

Drug: gemigliptin