CompletedPhase 4

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

Japan1,240 participantsStarted 2006-04

Plain-language summary

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

Who can participate

Age range

30 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
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 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: from April, 2006 to end of March, 2012

Trial details

NCT IDNCT00301392

SponsorTokyo University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03

View on ClinicalTrials.gov More Diabetes Mellitus trials