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

NCT02290301 | Completed

• 1 other identifier: LG-DPOS001
• Study Type: observational
• Target: 5,180
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time-to-event for the primary composite MACE(Major Adverse Cardiovascular Events) endpoint

  during the study period (2~4 years)

Study Arms (1)

Type 2 Diabetes Mellitus

Drug: gemigliptin

Interventions

gemigliptin DRUG

Type 2 Diabetes Mellitus

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• LG Life Sciences: lead

Study Sites (1)

Pusan National University Hospital

Busan, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33149182 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LC15-0444

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2014
• First Posted: November 14, 2014
• Study Start: June 28, 2013
• Primary Completion: November 30, 2017
• Study Completion: November 30, 2017
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

KR (1)