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NCT02290301

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

Completed Last updated 24 January 2019
What this trial tests

trial testing gemigliptin in Type 2 Diabetes Mellitus in 5,180 participants. Completed in 30 November 2017.

Timeline
28 June 2013
Primary endpoint
30 November 2017
30 November 2017

Quick facts

Lead sponsorLG Life Sciences
StatusCompleted
Study typeOBSERVATIONAL
Enrollment5,180
Start date28 June 2013
Primary completion30 November 2017
Estimated completion30 November 2017
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

LG Life Sciences — full company profile →

Who can join

19 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. A prospective cohort study on effects of gemigliptin on cardiovascular outcomes in patients with type 2 diabetes (OPTIMUS study).
    Kim EH, Kim SS, Kim DJ, Choi YS, et al · · 2020 · PMID 33149182 · DOI 10.1038/s41598-020-75594-5

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

Other LG Life Sciences trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02290301.

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