Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

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

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Atorvastatin; Atorvastatin Calcium; Pitavastatin

Criteria

Inclusion Criteria:

• Age: 25yrs~75yrs

• Fasting TG <400mg/dL, LDL-C ≥130mg/dL

• 3months > Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%

Exclusion Criteria:

• Type1 DM, Gestational diabetes

• Patient need to treat with Insulin

• Patient with operational treatment for severe diabetic complication

• Uncontrolled Hypothyroidism

• Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)

• Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)

• Renal disorder (Serum creatinine ≥ 2.0mg/dL)

• Hepatic disorder (AST or ALT ≥ 2.5 X UNL)

• Creatinine Kinase > 2.5 X UNL

• Gravida or lactation phase

• Administration of Atorvastatin, Rosuvastatin, Pitavastatin