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.
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
CCBR Aalborg, Aalborg, Denmark
CCBR A/S, Ballerup, Denmark
CCBR Vejle, Vejle, Denmark
Gemeinschaftspraxis am Bahnhof, Berlin-Spandau, Germany
Pharmakologisches Studienzentum Chemnitz, Chemnitz, Germany
Internistische Diabetische Schwerpunktpraxis Dr., Frankfurt Am Main, Germany
Internistische Gemeinschaftspraxis, Mainz, Germany
Gemeinschaftspraxis Dr. Senftleber, Dr. Kohler, Messkirch, Germany
Bhagwan Mahaveer Jain Heart Centre, Bangalore, India
Sri Ramachandra Medical College Hospital, Chennai, India
Apollo Hospitals, Hyderabaad, India
CARE Group of Hospitals, Hyderabaad, India
PD Hinduja Hospital, Mumbai, India
Andromed Breda, Breda, Netherlands
Andromed Eindhoven, Eindhoven, Netherlands
Andromed Noord, Groningen, Netherlands
Andromed Leiden, Leiden, Netherlands
Andromed Nijmegen, Nijmegen, Netherlands
Andromed Rotterdam, Rotterdam, Netherlands
Andromed Oost, Velp, Netherlands
Andromed Zoetermeer, Zoetermeer, Netherlands
Podlaski Osrodek Kardiologii, Bialystok, Poland
NZOZ GCP Dobra Praktyka Lekaska, Gruziadz, Poland
NZOZ Terapia Optima, Katowice, Poland
NZOZ Esculap, Przychodnia Lekary Rodzinnych, Losice, Poland
NZOZ Centrum, Poradnia Kardiologiczna, Siedlce, Poland
Spec. Gab. Lek. Internistyczno-Kardiologicznly, Tarnow, Poland
Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego, Tychy, Poland
Instytut Zywnosci i Zywienia, Warszawa, Poland
Lecznica PROSEN SMO, Warszawa, Poland
Szpital Wolski,im. Dr A. Gostynskiej, Warszawa, Poland
Synexus Reading Clinical Research Centre, Berkshire, United Kingdom
Synexus Lancashire Clinical Research Centre, Lancashire, United Kingdom
Synexus Merseyside Clinical Research Centre, Liverpool, United Kingdom
Synexus Manchester Clinical Research Centre, Manchester, United Kingdom