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

Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00309751
Enrollment
418
Registered
2006-04-03
Start date
2005-12-31
Completion date
2007-06-30
Last updated
2010-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Type II Diabetes Mellitus

Keywords

Kowa, Type II Diabetes Mellitus, Combined Dyslipidemia, pitavastatin, NK-104, Atorvastatin

Brief 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.

Interventions

DRUGPitavastatin

Pitavastatin 4 mg QD

DRUGAtorvastatin

Atorvastatin 20 mg

Sponsors

Kowa Research Europe
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)12 weeksPercent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary

MeasureTime frameDescription
Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target12 weeksNumber of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Countries

Denmark, Germany, India, Netherlands, Poland, United Kingdom

Participant flow

Participants by arm

ArmCount
Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
275
Atorvastatin 20 mg QD
Atorvastatin 20 mg once daily
137
Total412

Baseline characteristics

CharacteristicPitavastatin 4 mg QDAtorvastatin 20 mg QDTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
84 Participants44 Participants128 Participants
Age, Categorical
Between 18 and 65 years
191 Participants93 Participants284 Participants
Age Continuous59.1 years
STANDARD_DEVIATION 9.21
59.8 years
STANDARD_DEVIATION 9.06
59.4 years
STANDARD_DEVIATION 9.15
Sex: Female, Male
Female
120 Participants59 Participants179 Participants
Sex: Female, Male
Male
155 Participants78 Participants233 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
29 / —22 / —
serious
Total, serious adverse events
4 / —4 / —

Outcome results

Primary

Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)

Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Time frame: 12 weeks

ArmMeasureValue (MEAN)Dispersion
Pitavastatin 4 mg QDPercent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)-40.78 percent changeStandard Deviation 19.599
Atorvastatin 20 mg QDPercent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)-43.25 percent changeStandard Deviation 16.378
Secondary

Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target

Number of patients attaining National Cholesterol Education Program (NCEP)LDL-C target (LDL-C less than 160 mg/dL) at 12 weeks

Time frame: 12 weeks

ArmMeasureValue (NUMBER)
Pitavastatin 4 mg QDNumber of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target212 Participants
Atorvastatin 20 mg QDNumber of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target111 Participants

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026