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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02382159

Enrollment

1000

Registered

2015-03-06

Start date

2010-10-31

Completion date

2015-06-30

Last updated

2015-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complex Dyslipidemia

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,

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Other

Measure	Time frame	Description
Setting the sub-group by the result of lipid parameter	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)

Countries

South Korea

Outcome results