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

January 22, 2019 updated by: LG Life Sciences

An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Type 2 Diabetes Mellitus
Drug: gemigliptin

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LG Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2013

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

November 30, 2017

Study Registration Dates

First Submitted

November 7, 2014

First Submitted That Met QC Criteria

November 10, 2014

First Posted (Estimate)

November 14, 2014

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LG-DPOS001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Type 2 Diabetes Mellitus

Clinical Trials on gemigliptin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe