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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Glucose Intolerance	Other: life-style intervention; Drug: Life style interventions plus concomitant use of pitavastatin.	Phase 4

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1240 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Study Start Date :	April 2006
Actual Primary Completion Date :	March 2012
Actual Study Completion Date :	June 2012

Arms and Interventions

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Arm

Intervention/treatment

Pitavastatin; Administration of Pitavastatin

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).

Outcome Measures

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Primary Outcome Measures :

1. Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels [ Time Frame: from April, 2006 to end of March, 2012 ]

Secondary Outcome Measures :

1. Incidence of newly developed diabetes [ Time Frame: from April, 2006 to end of March, 2012 ]
2. Cumulative incidence of diabetes based on clinical diagnosis. [ Time Frame: from April, 2006 to end of March, 2012 ]
   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.
3. 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 ]
   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)
4. Time until development of diabetes; Improvement in glucose tolerance [ Time Frame: from April, 2006 to end of March, 2012 ]
5. 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 ]
6. Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization) [ Time Frame: from April, 2006 to end of March, 2012 ]
7. Incidence of coronary heart disease plus cerebral infarction [ Time Frame: from April, 2006 to end of March, 2012 ]
8. LDL-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ]
9. HDL-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ]
10. Triglyceride [ Time Frame: from April, 2006 to end of March, 2012 ]
11. RLP-cholesterol [ Time Frame: from April, 2006 to end of March, 2012 ]
12. Adiponectin [ Time Frame: from April, 2006 to end of March, 2012 ]
13. High sensitive CRP [ Time Frame: from April, 2006 to end of March, 2012 ]
14. Asymmetrical dimethyl arginine (ADMA) [ Time Frame: from April, 2006 to end of March, 2012 ]
15. Urinary 8-OHd [ Time Frame: from April, 2006 to end of March, 2012 ]
16. Fasting plasma glucose [ Time Frame: from April, 2006 to end of March, 2012 ]
17. 2-h plasma glucose during 75g oral glucose tolerance test [ Time Frame: from April, 2006 to end of March, 2012 ]
18. HbA1c [ Time Frame: from April, 2006 to end of March, 2012 ]
19. Insulin [ Time Frame: from April, 2006 to end of March, 2012 ]
20. HOMA-R [ Time Frame: from April, 2006 to end of March, 2012 ]
21. HOMA-β [ Time Frame: from April, 2006 to end of March, 2012 ]
22. Insulinogenic index [ Time Frame: from April, 2006 to end of March, 2012 ]
23. Time until dropout [ Time Frame: from April, 2006 to end of March, 2012 ]
24. Number of adverse events [ Time Frame: from April, 2006 to end of March, 2012 ]

Eligibility Criteria

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Ages Eligible for Study:	30 Years to 74 Years (Adult, Senior)
Sexes Eligible for Study:	All
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

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Locations

Japan
The University of Tokyo, Graduate School of Medicine
Bunkyo-ku, Tokyo, Japan, 113-8655

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Tsutomu Yamazaki, Professor, Tokyo University
ClinicalTrials.gov Identifier:	NCT00301392 History of Changes
Other Study ID Numbers:	J-PREDICT
First Posted:	March 10, 2006
Last Update Posted:	September 6, 2013
Last Verified:	September 2013

Keywords provided by Tsutomu Yamazaki, 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; Enzyme Inhibitors; Lipid Regulating Agents