- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02382159
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.
- Target disease: Patients with combined dyslipidemia accompanied by type 2 diabetes who has done exogenous visit or hospitalization from Jan 2010 to June 2014.
Study objective:
- 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.
- 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.
- 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
Conditions
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
-
-
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Bucheon, Korea, Republic of
- The Catholic University of Korea(Bucheon St. Mary's Hospital)
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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
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.
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
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.
- Patients have the result of lipid parameter test at baseline and after lipid-lowering drug for at least 3 months.
- Patients who have the result of lipid paraneter test (LDL-C ≥100mg/dL, TG ≥150mg/dL) at baseline.
- Patients who have no received lipid lowering drug fr at least 2 months prior to the baseline.
- Patients' age were > 20 years and <75 year.
Exclusion Criteria:
- Patients who ahs HbA1c≥9%
- 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
- Patients who have history of drug discontinuation by incresed liver enzyme or rhabdomyolysis.
- Patients received lipid-lowering drug and TZD(Thiazolidinediones) in study period
- Renal abnormality
- Alcoholism or Alcohol abuse
- Patients treated by Steroids.
- Pregnant or lactating woman
- 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
Additional Relevant MeSH Terms
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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