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Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

This study is currently recruiting participants.
Verified April 2012 by Tokyo University
Sponsor:
Information provided by (Responsible Party):
Hiroshi Satonaka, Tokyo University
ClinicalTrials.gov Identifier:
NCT00301392
First received: March 5, 2006
Last updated: April 3, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance.


Condition Intervention Phase
Diabetes Mellitus
Glucose Intolerance
 Other: life-style intervention
Drug: Life style intervventions plus concomitant use of pitavastatin.
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tokyo University:

Primary Outcome Measures:
  • Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of newly developed diabetes [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Cumulative incidence of diabetes based on clinical diagnosis. [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
    Cumulative incidence of diabetes based on clinical diagnosis defined as at least one of the following:(1) Typical symptoms of diabet plus 1 positive OGTT or fasting glucose levels, (2)HbA1c>=6.5% plus 1 positive OGTT or fasting glucose levels, (3)2 positive OGTT or fasting glucose levels.

  • Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
    Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels (from the first administration of the study drug after the randomization)

  • Time until development of diabetes; Improvement in glucose tolerance [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction. [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization) [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Incidence of coronary heart disease plus cerebral infarction [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • LDL-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • HDL-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Triglyceride [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • RLP-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Adiponectin [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • High sensitive CRP [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Asymmetrical dimethyl arginine (ADMA) [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Urinary 8-OHd [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Fasting plasma glucose [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • 2-h plasma glucose during 75g oral glucose tolerance test [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • HbA1c [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • HOMA-R [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • HOMA-β [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Insulinogenic index [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Time until dropout [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]
  • Number of adverse events [ Time Frame: from April, 2006 to end of March, 2012 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1240
Study Start Date: April 2006
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: life-style intervention
    As the life-style interventions aiming to reduce the major risks of developing diabetes mellitus, instruct the following four items:(1)set diet right, (2)maintain normal weight,(3)improve physical activity,(4)normalize smoking and alcohol drinking.
    Drug: Life style intervventions plus concomitant use of pitavastatin.
    Once-dailly dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tabletss of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
Detailed Description:

Diabetes mellitus and its complications are major health problems globally. People with impaired glucose tolerance (IGT) are at high risk of developing diabetes. It is therefore important to focus on preventing diabetes in individuals with IGT. HMG-CoA reductase inhibitors (statins) are widely used for hypercholesterolemia, one of the most frequent metabolic disorders. However, there is no direct evidence to whether statins are beneficial for preventing diabetes. This study is designed to compare the efficacy of life-style modification versus life-style modification with pitavastatin (a statin) administration, in individuals with IGT.

  Eligibility

Ages Eligible for Study:   30 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria for the screening test (within 6 months before screening):

  • LDL-cholesterol 100-159 mg/dl and/or total cholesterol 180-239 mg/dl

  • At least one of the following:

    1. Fasting plasma glucose 100-125 mg/dl, and/or casual (non-fasting) plasma glucose 120-199 mg/dl, and/or HbA1c 5.5-6.0%

    2. At least two of the following risk factors for impaired glucose tolerance:

      1. Second degree relative with diabetes
      2. BMI >= 24 kg/m2
      3. Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension
      4. Triglyceride >= 150 mg/dl, and/or HDL < 40 mg/dl
  • Written consent for participation in the study by their own volition after being provided sufficient explanation for the participation into this clinical trial

Inclusion Criteria for the entry (Confirmed by screening test):

-Impaired glucose tolerance by 75g oral glucose tolerance test (fasting plasma glucose <126 mg/dl and 2-h plasma glucose 140-199 mg/dl)

Exclusion Criteria:

  • History of diabetes (except gestational diabetes)
  • Fasting plasma glucose >= 126 mg/dl , and/or 2-h plasma glucose >= 200 mg/dl
  • HbA1c >= 6.5%
  • Diabetic retinopathy
  • Receiving with hormone replacement therapy
  • Pancreatic diseases ( e.g. pancreatitis, pancreatectomy, pancreatic cancer), Endocrine diseases ( e.g. Cushing's syndrome, acromegaly, pheochromocytoma, aldosteronism, hyperthyroidism )
  • Receiving statins, fibrates or anion exchange resins
  • Cancer or suspected cancer
  • History of gastrectomy
  • History of myocardial infarction, angina, or heart failure (NYHA Class >= III)
  • Severe hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg)
  • Renal disease, including serum creatinine >= 2.0 mg/dl
  • Hepatic disease, including transaminase (ALT or AST) >= 2 times the upper limit of normal
  • Women hoping to become pregnant during the intended study period

  • Contraindication or relative contraindication of Livalo® Tab(pitavastatin calcium)

    1. History of hypersensitivity to any of the ingredients of the product
    2. Severe hepatic disorder or biliary atresia
    3. Receiving cyclosporine
    4. Pregnant women, women suspected of being pregnant, or lactating women
    5. Patients receiving fibrates who also have laboratory evidence of abnormal renal function
  • Familial hypercholesterolemia
  • Drug abuse, alcoholism
  • Individuals who are ineligible in the opinion of the investigator
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00301392

Contacts
Contact: Tsutomu Yamazaki, MD,PhD +81-3-5800-9844 yama-tky@umin.ac.jp
Contact: Takashi Kadowaki, MD,PhD +81-3-5800-8815 kadowaki-3im@h.u-tokyo.ac.jp

Locations
Japan
The University of Tokyo, Graduate School of Medicine Recruiting
Bunkyo-ku, Tokyo, Japan, 113-8655
Principal Investigator: Takashi Kadowaki, MD, PhD            
Sponsors and Collaborators
Tokyo University
Investigators
Study Chair: Takashi Kadowaki, MD,PhD Professor, Department of Metabolic Diseases, Graduate School of Medicine, the University of Tokyo.
  More Information

No publications provided

Responsible Party: Hiroshi Satonaka, Professor, Tokyo University
ClinicalTrials.gov Identifier: NCT00301392     History of Changes
Other Study ID Numbers: J-PREDICT
Study First Received: March 5, 2006
Last Updated: April 3, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Tokyo University:
Glucose intolerance
Diabetes mellitus
Statins,HMG-CoA

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia
Pitavastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013