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

Completed

• Conditions: Complex Dyslipidemia

• Registration Number: NCT02382159
• Lead Sponsor: Yooyoung Pharmaceutical Co., Ltd.

Brief Summary

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,

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2015-02-25
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-06
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-15
• Last Update Posted: 2015-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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