Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Verified by: Kowa Research Europe, February 2010
First Received: December 8, 2005 | Last Updated: February 17, 2010 | Phase: Phase 3 | Start Date: December 2005
Overall Status: Completed | Estimated Enrollment: 418
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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...

Brief Summary

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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • Study Primary Completion Date: June 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Pitavastatin 4 mg QD
    • Pitavastatin 4 mg once daily
  • Active Comparator: Atorvastatin 20 mg QD
    • Atorvastatin 20 mg once daily

Outcome Measures for this Clinical Trial

Primary Measures

  • Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target
    • Time Frame: 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Clinical Trial Investigator Information

Lead Investigator: Kowa Research Europe Industry

Overall Clinical Trial Officials and Contacts

Dragos Budinski, Med Dr. Study Director Kowa Research Europe  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

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

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