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

Condition(s) targeted: Type II Diabetes Mellitus; Dyslipidemia

Intervention: Pitavastatin (Drug); Atorvastatin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Kowa Research Europe

Official(s) and/or principal investigator(s):
Dragos Budinski, Med Dr., Study Director, Affiliation: Kowa Research Europe

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Percent change from baseline low density lipoprotein-cholesterol (LDL-C)

Secondary outcome:

Changes in lipid and lipoprotein measures

Safety and tolerability

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

CCBR a/S, Ballerup, Denmark

CCBR Vejle, Vejle, Denmark

CCBR Aalborg, Aalborg, Denmark

Pharmakologisches Studienzentum Chemnitz, Chemnitz, Germany

Gemeinschaftspraxis am Bahnhof, Berlin-Spandau, 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

PD Hinduja Hospital, Mumbai, India

Apollo Hospitals, Hyderabaad, India

CARE Group of Hospitals, Hyderabaad, India

Andromed Rotterdam, Rotterdam, Netherlands

Andromed Noord, Groningen, Netherlands

Andromed Zoetermeer, Zoetermeer, Netherlands

Andromed Oost, Velp, Netherlands

Andromed Leiden, Leiden, Netherlands

Andromed Nijmegen, Nijmegen, Netherlands

Andromed Breda, Breda, Netherlands

Andromed Eindhoven, Eindhoven, Netherlands

Instytut Zywnosci i Zywienia, Warszawa, Poland

Szpital Wolski,im. Dr A. Gostynskiej, Warszawa, Poland

NZOZ Centrum, Poradnia Kardiologiczna, Siedlce, Poland

NZOZ Esculap, Przychodnia Lekary Rodzinnych, Losice, Poland

Podlaski Osrodek Kardiologii, Bialystok, Poland

NZOZ GCP Dobra Praktyka Lekaska, Gruziadz, Poland

Spec. Gab. Lek. Internistyczno-Kardiologicznly, Tarnow, Poland

NZOZ Terapia Optima, Katowice, Poland

Lecznica PROSEN SMO, Warszawa, Poland

Woj.Szp.Spec.Nr 1 im. Prof. J. Gasinskiego, Tychy, Poland

Synexus Manchester Clinical Research Centre, Manchester, United Kingdom

Synexus Lancashire Clinical Research Centre, Lancashire, United Kingdom

Synexus Merseyside Clinical Research Centre, Liverpool, United Kingdom

Synexus Reading Clinical Research Centre, Berkshire, United Kingdom

Starting date: November 2005
Ending date: August 2008
Last updated: April 10, 2008