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

Kowa

Status and phase: Completed; Phase 3

Conditions: Type II Diabetes Mellitus; Dyslipidemia

Treatments: Drug: Atorvastatin; Drug: Pitavastatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00309751

NK-104-305

Details and patient eligibility

About

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.

Enrollment: 418 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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418 participants in 2 patient groups

Pitavastatin 4 mg QD

Experimental group

Description:

Pitavastatin 4 mg once daily

Treatment:

Drug: Pitavastatin

Atorvastatin 20 mg QD

Active Comparator group

Description:

Atorvastatin 20 mg once daily

Treatment:

Drug: Atorvastatin