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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tsutomu Yamazaki, Tokyo University
ClinicalTrials.gov Identifier:
NCT00301392
First received: March 5, 2006
Last updated: September 5, 2013
Last verified: September 2013

March 5, 2006
September 5, 2013
April 2006
March 2012   (final data collection date for primary outcome measure)
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 ]
  • Development of diabetes based on fasting glucose levels
  • Development of diabetes based on 1 positive OGTT
Complete list of historical versions of study NCT00301392 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Development of diabetes based on clinical diagnosis
  • Time until development of diabetes
  • Improvement in glucose tolerance
  • Incidence of myocardial infarction
  • Incidence of angina
  • Incidence of congestive heart disease
  • Incidence of coronary revascularization
  • Incidence of cerebral hemorrhage
  • Incidence of cerebral infarction
  • Incidence of subarachnoid hemorrhage
  • Incidence of transient ischemic attack
  • Incidence of arteriosclerosis obliterans
  • Incidence of leg amputation
  • Endovascular intervention in leg arteries
  • Surgical intervention in leg arteries
  • Sudden death
  • Incidence of coronary heart disease
  • Incidence of coronary heart disease plus cerebral infarction
  • LDL-cholesterol
  • HDL-cholesterol
  • Triglyceride
  • RLP-cholesterol
  • Adiponectin
  • High sensitive CRP
  • Asymmetrical dimethyl arginine(ADMA)
  • Urinary 8-OhdG
  • Fasting plasma glucose
  • 2-h plasma glucose post-75g oral glucose tolerance
  • HbA1c
  • Insulin
  • HOMA-R
  • HOMA-beta
  • Insulinogenic index
  • Number of adverse events
Not Provided
Not Provided
 
Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)

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

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diabetes Mellitus
  • Glucose Intolerance
  • 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 interventions plus concomitant use of pitavastatin.
    Once-daily dosing of pitavastatin 1 mg(1 tablet of Livalo Tab 1 mg), or 2mg(2 tablets of Livalo Tab 1mg or 1 tablet of Livalo Tab 2mg);Dosing period of pitavastatin should be 60 months.(max.84 months).
Pitavastatin
Administration of Pitavastatin
Interventions:
  • Other: life-style intervention
  • Drug: Life style interventions plus concomitant use of pitavastatin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1240
June 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
30 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00301392
J-PREDICT
No
Tsutomu Yamazaki, Tokyo University
Tokyo University
Not Provided
Study Chair: Takashi Kadowaki, MD,PhD Professor, Department of Metabolic Diseases, Graduate School of Medicine, the University of Tokyo.
Tokyo University
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP