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

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Primary Purpose

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

life-style intervention

Life style interventions plus concomitant use of pitavastatin.

About this trial

This is an interventional prevention trial for Diabetes Mellitus focused on measuring Glucose intolerance, Diabetes mellitus, Statins,HMG-CoA

Eligibility Criteria

30 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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% At least two of the following risk factors for impaired glucose tolerance: Second degree relative with diabetes BMI >= 24 kg/m2 Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension 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) History of hypersensitivity to any of the ingredients of the product Severe hepatic disorder or biliary atresia Receiving cyclosporine Pregnant women, women suspected of being pregnant, or lactating women 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

Sites / Locations

The University of Tokyo, Graduate School of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Pitavastatin

Arm Description

Administration of Pitavastatin

Outcomes

Primary Outcome Measures

Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels

Secondary Outcome Measures

Incidence of newly developed diabetes

Cumulative incidence of diabetes based on clinical diagnosis.

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

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

Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.

Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)

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-OHd

Fasting plasma glucose

2-h plasma glucose during 75g oral glucose tolerance test

HbA1c

Insulin

HOMA-R

HOMA-β

Insulinogenic index

Time until dropout

Number of adverse events

Full Information

NCT ID

NCT00301392

First Posted

March 5, 2006

Last Updated

September 5, 2013

Sponsor

Tokyo University

1. Study Identification

Unique Protocol Identification Number

NCT00301392

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

April 2006 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Tokyo University

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Glucose Intolerance

Keywords

Glucose intolerance, Diabetes mellitus, Statins,HMG-CoA

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

1240 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pitavastatin

Arm Type

Other

Arm Description

Administration of Pitavastatin

Intervention Type

Other

Intervention Name(s)

life-style intervention

Intervention Description

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

Drug

Intervention Name(s)

Life style interventions plus concomitant use of pitavastatin.

Intervention Description

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).

Primary Outcome Measure Information:

Title

Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels

Time Frame