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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02290301
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
LG Life Sciences

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.


Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: gemigliptin

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Study Type : Observational
Actual Enrollment : 5180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study to Evaluate Cardiovascular Outcomes of Patients With Type 2 Diabetes Mellitus Treated With Gemigliptin
Actual Study Start Date : June 28, 2013
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint [ Time Frame: during the study period (2~4 years) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02290301


Locations
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Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of
Sponsors and Collaborators
LG Life Sciences
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Responsible Party: LG Life Sciences
ClinicalTrials.gov Identifier: NCT02290301    
Other Study ID Numbers: LG-DPOS001
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases