An Observational Study to Evaluate Cardiovascular Outcome... | NCT02290301

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

NCT02290301

Sponsor

LG Life Sciences

Status

Completed

Last Update Posted

Jan 24, 2019Actual

Enrollment

5,180Actual

Phase

Not provided

Conditions

Type 2 Diabetes Mellitus

Interventions

gemigliptin

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 28, 2013Actual

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Nov 30, 2017Actual

First Submitted Date

Nov 7, 2014

First Submission Date that Met QC Criteria

Nov 10, 2014

First Posted Date

Nov 14, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2019

Last Update Posted Date

Jan 24, 2019Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,180Actual

Label	Type	Description	Intervention Names
Type 2 Diabetes Mellitus			Drug: gemigliptin

Name	Type	Description	Arm Group Labels	Other Names
gemigliptin	Drug		Type 2 Diabetes Mellitus

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33149182	Derived	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.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases