Phase 3 Completed N=418 Randomized Quadruple-blind Treatment

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

Type II Diabetes Mellitus · Dyslipidemia

Source: ClinicalTrials.gov NCT00309751 ↗

Enrolled (actual)

418

Serious AEs

—

Results posted

Jan 2010

Primary outcomePrimary: Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) — -40.78; -43.25 percent change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)	-40.78; -43.25	—
SECONDARY Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target	212; 111	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00309751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.