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

Phase 4

Completed

• Conditions: Diabetes Mellitus; Glucose Intolerance
• Interventions: Other: life-style intervention; Drug: Life style interventions plus concomitant use of pitavastatin.

• Registration Number: NCT00301392
• Lead Sponsor: Tokyo University

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.

Study Timeline

• Study First Submitted: 2006-03-05
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-10
• Study Start: 2006-04
• Primary Completion: 2012-03
• Study Completion: 2012-06
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-05
• Last Update Posted: 2013-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pitavastatin	life-style intervention	Administration of Pitavastatin
Pitavastatin	Life style interventions plus concomitant use of pitavastatin.	Administration of Pitavastatin

Primary Outcome Measures

Name	Time	Method
Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels	from April, 2006 to end of March, 2012

Secondary Outcome Measures

Name	Time	Method
Incidence of newly developed diabetes	from April, 2006 to end of March, 2012
Cumulative incidence of diabetes based on clinical diagnosis.	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.
Cumulative incidence of newly developed diabetes based on 1 positive OGTT or fasting glucose levels	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)
Time until development of diabetes; Improvement in glucose tolerance	from April, 2006 to end of March, 2012
Incidence of any cardiovascular disease (myocardial infarction, angina, congestive heart disease, coronary revascularization, cerebral hemorrhage, cerebral infarction.	from April, 2006 to end of March, 2012
Incidence of coronary heart disease (myocardial infarction, angina, coronary revascularization)	from April, 2006 to end of March, 2012
LDL-cholesterol	from April, 2006 to end of March, 2012
HDL-cholesterol	from April, 2006 to end of March, 2012
Triglyceride	from April, 2006 to end of March, 2012
RLP-cholesterol	from April, 2006 to end of March, 2012
Adiponectin	from April, 2006 to end of March, 2012
High sensitive CRP	from April, 2006 to end of March, 2012
Asymmetrical dimethyl arginine (ADMA)	from April, 2006 to end of March, 2012
Urinary 8-OHd	from April, 2006 to end of March, 2012
Fasting plasma glucose	from April, 2006 to end of March, 2012
Incidence of coronary heart disease plus cerebral infarction	from April, 2006 to end of March, 2012
2-h plasma glucose during 75g oral glucose tolerance test	from April, 2006 to end of March, 2012
HbA1c	from April, 2006 to end of March, 2012
Insulin	from April, 2006 to end of March, 2012
HOMA-R	from April, 2006 to end of March, 2012
HOMA-β	from April, 2006 to end of March, 2012
Insulinogenic index	from April, 2006 to end of March, 2012
Time until dropout	from April, 2006 to end of March, 2012
Number of adverse events	from April, 2006 to end of March, 2012

Trial Locations

Locations (1)

The University of Tokyo, Graduate School of Medicine; 🇯🇵 Bunkyo-ku, Tokyo, Japan