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Diabetes MellitusPhase 4NCT00301392

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

A Phase 4 study testing life-style intervention and Life style interventions plus concomitant use of pitavastatin. in people with Diabetes Mellitus and Glucose Intolerance, run by Tokyo University at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 30 to 74 years
Conditions the study is for
Diabetes Mellitus, Glucose Intolerance
What is being tested?
life-style intervention and Life style interventions plus concomitant use of pitavastatin.
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,240 participants
Where
1 siteJapan
Study dates
Apr 2006to Jun 2012
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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)

Who cannot join

  • 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 )
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  • 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

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • The University of Tokyo, Graduate School of Medicine

    Bunkyo-ku, Tokyo, 113-8655

Other trials in Japan

About this study

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

Read the 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.

Being tested
life-style intervention, Life style interventions plus concomitant use of pitavastatin.
Keywords
Glucose intolerance, Diabetes mellitus, Statins,HMG-CoA
Medical subject headings
Diabetes Mellitus, Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • life-style interventionOther

    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.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).

Study groups in NCT00301392
Study groupRoleWhat they receive
PitavastatinOtherAdministration of Pitavastatin
Receives: Other: life-style intervention; Drug: Life style interventions plus concomitant use of pitavastatin.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (24)

  1. Incidence of newly developed diabetes

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

  2. 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.

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

  3. 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)

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

  4. Time until development of diabetes; Improvement in glucose tolerance

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

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

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

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

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

  7. Incidence of coronary heart disease plus cerebral infarction

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

  8. LDL-cholesterol

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

  9. HDL-cholesterol

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

  10. Triglyceride

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

  11. RLP-cholesterol

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

  12. Adiponectin

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

  13. High sensitive CRP

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

  14. Asymmetrical dimethyl arginine (ADMA)

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

  15. Urinary 8-OHd

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

  16. Fasting plasma glucose

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

  17. 2-h plasma glucose during 75g oral glucose tolerance test

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

  18. HbA1c

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

  19. Insulin

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

  20. HOMA-R

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

  21. HOMA-β

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

  22. Insulinogenic index

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

  23. Time until dropout

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

  24. Number of adverse events

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionMar 2012
  4. Study completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00301392
Sponsor's protocol ID
J-PREDICT
Status last verified
Sep 2013
First submitted
5 Mar 2006
Last updated
6 Sep 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing life-style intervention and Life style interventions plus concomitant use of pitavastatin. in people with Diabetes Mellitus and Glucose Intolerance, run by Tokyo University at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels (time frame: from April, 2006 to end of March, 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00301392.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2013.

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