NCT02290301

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 5,180 (actual)
• Sponsor: LG Life Sciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	gemigliptin

Timeline

• Start date: 2013-06-28
• Primary completion: 2017-11-30
• Completion: 2017-11-30
• First posted: 2014-11-14
• Last updated: 2019-01-24

Locations

1 site across 1 country: South Korea