A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.

July 15, 2015 updated by: Yooyoung Pharmaceutical Co., Ltd.

Observational, Retrospective, Multi-center Study for Therapeutic Practice Pattern of Lipid-lowering Drug and Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.

  1. Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014.
  2. Study objective:

    1. The objective of this study is to Identifying the lipid parameter variation when treating patients who have dyslipidemia of type 2 diabetes for 3±1 months.
    2. After treating patients who have dyslipidemia of type 2 diabetes for 3±1 months, identifying the reason why changing method of drug dosage and pharmacotherapy.
    3. If the drug dosage and pharmacotherapy have been changed, Identifying the lipid parameter variation when treating patients by altered drugs for 3±1 months,

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bucheon, Korea, Republic of
        • The Catholic University of Korea(Bucheon St. Mary's Hospital)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. Base-line (The starting time of treating lipid-lowering drug within 3 months period of 2010 ~ 2013 years)

    • Background of Patients: Basic information(Height, Weight), Smoking, Drinking and other related illness.
    • Hypoglucemic agent, Diabetes test(Fasting blood glucose, GL test, Glycated Hemoglobin)
    • At the time of Starting the treating lipid-lowering drug, total Cholesterol, TG, LDL-C, HDL-C checked before treating lipid-lowering drug.
  2. After 3±1 months from base-line

    • Hypoglycemic agent, Diabetes test
    • Total Cholesterol, TG, LDL-C at the point of 3±1 months from treating changed lipid-lowering drug, and the reason of drug dosage and pharmacotherapy
  3. After 3±1 months from treating by changed lipid-lowering drug

    • Hypoglycemic agent, Diabetes test
    • Total Cholesterol, TG, LDL-C, HDL-C at the point of 3±1 months from treating changed lipid-lowering drug.

Description

Inclusion Criteria:

Among the patients, who has been hospitalized or visited the Outpatient Department OPD, who has dyslipidemia of type 2 diabetes.

  1. Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months.
  2. Patients who have the result of lipid paraneter test (LDL-C ≥100mg/dL, TG ≥150mg/dL) at baseline.
  3. Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline.
  4. Patients' age were > 20 years and <75 year.

Exclusion Criteria:

  1. Patients who ahs HbA1c≥9%
  2. Patients who have no the result of lipid parameter test at baseline and at baseline and after lipid-lowering drug for at least 3 months
  3. Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis.
  4. Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period
  5. Renal abnormality
  6. Alcoholism or Alcohol abuse
  7. Patients treated by Steroids.
  8. Pregnant or lactating woman
  9. Patients who are judged as not suitable for this study by Investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.
Time Frame: Over 3±1 months
Increasing LDL-C + Triglyceride(TG)Decreasing HDL-C + Increasing TG
Over 3±1 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.
Time Frame: Over 3±1 months
Increasing LDL-C + TG Decreasing HDL-C + Increasing TG
Over 3±1 months
Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.
Time Frame: Over 3±1 months
Increasing LDL-C + TGDecreasing HDL-C + Increasing TG
Over 3±1 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Setting the sub-group by the result of lipid parameter
Time Frame: Basis on the Base-line
Decreasing HDL-C: HDL-C≤40mg/dL(Man), ≤50mg/dL(Woman) Non-decreasing HDL-C: HDL-C≤40mg/dL(Man), >50mg/dL(Woman)
Basis on the Base-line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sung-Rae Kim, M.D, Catholic University of Korea (Bucheon St.Mary's Hospital)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

February 25, 2015

First Submitted That Met QC Criteria

March 2, 2015

First Posted (Estimate)

March 6, 2015

Study Record Updates

Last Update Posted (Estimate)

July 17, 2015

Last Update Submitted That Met QC Criteria

July 15, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • YYP-OS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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