NCT00301392

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,240 (actual)
• Sponsor: Tokyo University · Academic / Other
• Sex: All
• Age: 30 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2006-04-01
• Primary completion: 2012-03-01
• Completion: 2012-06-01
• First posted: 2006-03-10
• Last updated: 2013-09-06

Locations

1 site across 1 country: Japan