Completed

NCT Number: NCT02382159

A Observational Study to Evaluate Lipid-lowering Drug 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,

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Key information

Conditions

Complex Dyslipidemia

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bucheon-si, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

Secondary outcomes

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
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

Other outcomes

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)

Sponsors and collaborators

Lead sponsor

Yooyoung Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Mar 6, 2015
Registry last updated: Jul 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.