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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00309751
Recruitment Status : Completed
First Posted : April 3, 2006
Results First Posted : January 18, 2010
Last Update Posted : February 23, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type II Diabetes Mellitus Dyslipidemia Drug: Pitavastatin Drug: Atorvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Pitavastatin Vs. Atorvastatin (Following Up-Titration) in Patients With Type II Diabetes Mellitus and Combined Dyslipidemia
Study Start Date : December 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pitavastatin 4 mg QD
Pitavastatin 4 mg once daily
Drug: Pitavastatin
Pitavastatin 4 mg QD

Active Comparator: Atorvastatin 20 mg QD
Atorvastatin 20 mg once daily
Drug: Atorvastatin
Atorvastatin 20 mg
Other Name: Lipitor

Primary Outcome Measures :
  1. Percent Change From Baseline Low Density Lipoprotein Cholesterol (LDL-C) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Number of Patients Attaining National Cholesterol Education Program (NCEP) LDL-C Target [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00309751

CCBR Aalborg
Aalborg, Denmark
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
Warszawa, Poland
Szpital Wolski,im. Dr A. Gostynskiej
Warszawa, Poland
United Kingdom
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
Sponsors and Collaborators
Kowa Research Europe
Study Director: Dragos Budinski, Med Dr. Kowa Research Europe

Responsible Party: Dragos Budinski, MD, Kowa Research Europe Identifier: NCT00309751     History of Changes
Other Study ID Numbers: NK-104-305
First Posted: April 3, 2006    Key Record Dates
Results First Posted: January 18, 2010
Last Update Posted: February 23, 2010
Last Verified: February 2010

Keywords provided by Kowa Research Europe:
Type II Diabetes Mellitus
Combined Dyslipidemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipid Metabolism Disorders
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors