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

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kowa Research Europe
• Treatments: Atorvastatin; Atorvastatin Calcium; Pitavastatin

Criteria

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