Phase 3
N=418
Study Comparing Pitavastatin and Atorvastatin in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Type II Diabetes Mellitus · Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00309751 ↗Enrolled (actual)
418
Serious AEs
—
Results posted
Jan 2010
Primary outcome: Primary: Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) — -40.78; -43.25 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pitavastatin (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kowa Research Europe
- Primary completion
- Jun 2007
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 | — |
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.
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
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.