Skip to main content
OpenTrials
Completed

NCT Number: NCT02290301

An Observational Study to Evaluate Cardiovascular Outcomes of T2DM PatientsTreated 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pusan National University Hospital

Busan, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemigliptin

Drug

Primary outcomes

  1. Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint

    Time frame: during the study period (2~4 years)

Sponsors and collaborators

Lead sponsor

LG Life Sciences

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Nov 14, 2014
Registry last updated
Jan 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.