Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment gemigliptin
Sponsor LG Life Sciences
Start date June 2013
End date December 2017
Trial size 5180 participants
Trial identifier NCT02290301, LG-DPOS001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
gemigliptin

Primary Outcomes

Measure
Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint
time frame: during the study period (2~4 years)

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by LG Life Sciences.