Official Title: “Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia”

The purpose of this study is to compare the efficacy and safety of pitavastatin with that of atorvastatin in patients with type II diabetes mellitus (type II DM) and combined dyslipidemia.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: November 2007

Intervention(s) in this Clinical Trial

• Drug: Pitavastatin
  • 4 mg QD
• Drug: Atorvastatin
  • Atorvastatin 20 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Pitavastatin
• Active Comparator: 2
  • Atorvastatin

Primary Measures

• Percent change from baseline low density lipoprotein-cholesterol (LDL-C)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Changes in lipid and lipoprotein measures
  • Time Frame: 12 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Males and females (ages 18-75 years)
• Type II DM treated with oral anti-diabetic medication (sulfonylurea, metformin, glitazones, or combination therapy)
• Must have been following a restrictive diet
• Diagnosis of combined dyslipidemia

Exclusion Criteria:

• Homozygous familial hypercholesterolemia
• Conditions which may cause secondary dyslipidemia
• Uncontrolled diabetes mellitus
• Abnormal pancreatic, liver, or renal function
• Abnormal serum creatine kinase (CK) above the pre-specified level
• Significant heart disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kowa Research Europe

Overall Clinical Trial Officials and Contacts

Dragos Budinski, Med Dr. Study Director Kowa Research Europe  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00309751

Study ID Number: NK-104-305

ClinicalTrials.gov Identifier: NCT00309751

Health Authority: Poland: Ministry of Health