Clinical trial NCT02382159: A Observational Study to Evaluate Lipid-lowering Drug Its Effect on Parameters in Dyslipidemia of Type 2 Diabetes.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complex Dyslipidemia
Lead sponsor: Yooyoung Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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,


Eligibility criteria: 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.

Primary outcomes:
measure: Variation of the Lipid parameter pattern patients who are treated by lipid-lowering drug.
timeFrame: Over 3±1 months
Secondary outcomes:
measure: The reason why changed drug dosage and pharmacotherapy after patients taken lipid-lowering drug.
timeFrame: Over 3±1 months
measure: Variation for lipid parameter when the patients who are treated for 3±1 months by lipid-lowering drug.
timeFrame: Over 3±1 months
Other outcomes:
measure: Setting the sub-group by the result of lipid parameter
timeFrame: Basis on the Base-line
Locations:
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea(Bucheon St. Mary's Hospital)
Study officials:
affiliation: Catholic University of Korea (Bucheon St.Mary's Hospital)
name: Sung-Rae Kim, M.D
role: PRINCIPAL_INVESTIGATOR
References: