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

NCT ID: NCT02290301

Last Updated: 2019-01-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5180 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-28
• Study Completion Date: 2017-11-30

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Type 2 Diabetes Mellitus

gemigliptin

Intervention Type: DRUG

Interventions

gemigliptin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LG Life Sciences

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pusan National University Hospital

Busan, , South Korea

Countries

South Korea

References

Kim EH, Kim SS, Kim DJ, Choi YS, Lee CW, Ku BJ, Cha KS, Song KH, Kim DK, Kim IJ. A prospective cohort study on effects of gemigliptin on cardiovascular outcomes in patients with type 2 diabetes (OPTIMUS study). Sci Rep. 2020 Nov 4;10(1):19033. doi: 10.1038/s41598-020-75594-5.

Reference Type: DERIVED

PMID: 33149182 (View on PubMed)

Other Identifiers

LG-DPOS001

Identifier Type: -

Identifier Source: org_study_id