to Evaluate the Safety and Efficacy of Pitavastatin in Patients With IFG and Hyperlipidemia

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective

: To evaluate that there is no different effect on HbA1c between routine lipid lowering therapy(Livalo 2mg) and intensive lipid lowering therapy(Livalo 4mg) in the hyperlipidemic patients with impaired fasting glucose (IFG).

H0: µT-µC ≥ 0.4 vs H1: µT-µC < 0.4

µT = the change of HbA1c in the test drug (Pitavastatin 4 MG) µC = the change of HbA1c in the control drug (Pitavastatin 2 MG)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Collaborators: Ajou University School of Medicine; Asan Medical Center; Chonbuk National University Hospital; Chonnam National University Hospital; Chungnam National University Hospital; Dong-A University Hospital; Eulji University Hospital; Gangnam Severance Hospital; Hallym University Medical Center; Hanllym University Medical Center; Korea University Guro Hospital; Korea University Guro Hospitla; Kyunghee University Medical Center; Samsung Medical Center; Seoul National University Bundang Hospital; Seoul National University Hospital; Severance Hospital; The Catholic Univ. of Korea Daejeon St. Marys Hostpial; The Catholic University of Korea; The Catholic University of Korea Uijeongbu St.Marys Hostpial; The Catholic University of Korea Yeouido St.Marys Hostpial; Ulsan University Hospital; Yeungnam University Hospital; Youngnam University Medical Center
• Treatments: Calcium; Calcium, Dietary; Pitavastatin

Criteria

Inclusion Criteria:

1. Male and Female patients who are more than 20 years old or 70 years old or less.

2. Patient who voluntarily sign on written informed consent form

3. Patient who LDL-C ≥ 100mg/dl or was diagnosed with hyperlipidemia

4. Patient who was suspected with Imparied Fasting Glucose (IFG) and satisfy FPG level ≥ 100mg/dL and < 126mg/dL when FPG measured twice.

Exclusion Criteria:

1. Patient who has familial hypercholesterolemia

2. Patient who has been diagnosed with Type1, Type2 DM or secondary DM(diabetes mellitus) at the screening visit (Diagnostic criteria of DM: HbA1c≥ 6.5%)

3. Patient who has received antidiabetic within 6weeks to the screening visit

4. Patient who has been taking insulin continuously or to be needed in the future

5. Patient who has a history of gastrectomy

6. Patient who is suspected or diagnosed with malignant tumor within last 10 years

7. Patient who has serious pancreatic disease or endocrine disorders

8. Patient who currently takes Cyclosporine

9. Patient who has a medical history of hypersensitivity to Pitavastatin calcium

10. Patient who has suspected renal failure (serum creatinine ≥2.0 mg/dL)

11. Patient who has suspected liver dysfunction (more than 2.5 times the upper limit of normal AST or ALT)

12. Patient who has more than 3 times the upper limit of normal CPK

13. Patient who is breastfeeding, pregnant or planning pregnancy

14. Patient who deemed inappropriate as subject in the opinion of the Principal Investigator or Investigator