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

NCT ID: NCT00301392

Last Updated: 2013-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2012-06-30

Brief Summary

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

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.

Conditions

Diabetes Mellitus; Glucose Intolerance

Keywords

Glucose intolerance; Diabetes mellitus; Statins,HMG-CoA

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Pitavastatin

Administration of Pitavastatin

Group Type: OTHER

life-style intervention

Intervention Type: OTHER

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.

Life style interventions plus concomitant use of pitavastatin.

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: OTHER

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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

-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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tokyo University

OTHER

Sponsor Role: lead

Responsible Party

Tsutomu Yamazaki

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takashi Kadowaki, MD,PhD

Role: STUDY_CHAIR

Professor, Department of Metabolic Diseases, Graduate School of Medicine, the University of Tokyo.

Locations

The University of Tokyo, Graduate School of Medicine

Bunkyo-ku, Tokyo, Japan

Countries

Japan

Other Identifiers

J-PREDICT

Identifier Type: -

Identifier Source: org_study_id