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

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: gemigliptin

• Registration Number: NCT02290301
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Study First Submitted: 2014-11-07
• Study First Submitted QC: 2014-11-10
• Study First Posted: 2014-11-14
• Primary Completion: 2017-11-30
• Study Completion: 2017-11-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-22
• Last Update Posted: 2019-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5180

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 2 Diabetes Mellitus	gemigliptin	-

Primary Outcome Measures

Name	Time	Method
Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint	during the study period (2~4 years)

Trial Locations

Locations (1)

Pusan National University Hospital; 🇰🇷 Busan, Korea, Republic of