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

Phase 3

Completed

Conditions: Type II Diabetes Mellitus
Dyslipidemia

Interventions: Drug: Pitavastatin
Drug: Atorvastatin

Registration Number: NCT00309751

Lead Sponsor: Kowa Research Europe

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 418

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin 4 mg QD	Pitavastatin	Pitavastatin 4 mg once daily
Atorvastatin 20 mg QD	Atorvastatin	Atorvastatin 20 mg once daily

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C)	12 weeks	Percent change from baseline to Week 12 low density lipoprotein cholesterol (LDL-C)

Secondary Outcome Measures

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

Trial Locations

Locations (35): Andromed Eindhoven
🇳🇱
Eindhoven, Netherlands
Andromed Nijmegen
🇳🇱
Nijmegen, Netherlands
CCBR Aalborg
🇩🇰
Aalborg, Denmark
Synexus Manchester Clinical Research Centre
🇬🇧
Manchester, United Kingdom
NZOZ Terapia Optima
🇵🇱
Katowice, Poland
Internistische Gemeinschaftspraxis
🇩🇪
Mainz, Germany
Andromed Rotterdam
🇳🇱
Rotterdam, Netherlands
Andromed Zoetermeer
🇳🇱
Zoetermeer, Netherlands
NZOZ Centrum, Poradnia Kardiologiczna
🇵🇱
Siedlce, Poland
PD Hinduja Hospital
🇮🇳
Mumbai, India
NZOZ GCP Dobra Praktyka Lekaska
🇵🇱
Gruziadz, Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly
🇵🇱
Tarnow, Poland
Lecznica PROSEN SMO
🇵🇱
Warszawa, Poland
Bhagwan Mahaveer Jain Heart Centre
🇮🇳
Bangalore, India
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego
🇵🇱
Tychy, Poland
Andromed Noord
🇳🇱
Groningen, Netherlands
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler
🇩🇪
Messkirch, Germany
Instytut Zywnosci i Zywienia
🇵🇱
Warszawa, Poland
Synexus Reading Clinical Research Centre
🇬🇧
Berkshire, United Kingdom
Andromed Leiden
🇳🇱
Leiden, Netherlands
Andromed Oost
🇳🇱
Velp, Netherlands
CCBR A/S
🇩🇰
Ballerup, Denmark
CCBR Vejle
🇩🇰
Vejle, Denmark
Internistische Diabetische Schwerpunktpraxis Dr.
🇩🇪
Frankfurt Am Main, Germany
Gemeinschaftspraxis am Bahnhof
🇩🇪
Berlin-Spandau, Germany
Pharmakologisches Studienzentum Chemnitz
🇩🇪
Chemnitz, Germany
Andromed Breda
🇳🇱
Breda, Netherlands
Sri Ramachandra Medical College Hospital
🇮🇳
Chennai, India
Apollo Hospitals
🇮🇳
Hyderabaad, India
NZOZ Esculap, Przychodnia Lekary Rodzinnych
🇵🇱
Losice, Poland
Synexus Lancashire Clinical Research Centre
🇬🇧
Lancashire, United Kingdom
Synexus Merseyside Clinical Research Centre
🇬🇧
Liverpool, United Kingdom
CARE Group of Hospitals
🇮🇳
Hyderabaad, India
Podlaski Osrodek Kardiologii
🇵🇱
Bialystok, Poland
Szpital Wolski,im. Dr A. Gostynskiej
🇵🇱
Warszawa, Poland