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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012430
Receipt No. R000014547
Scientific Title Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Date of disclosure of the study information 2013/11/28
Last modified on 2018/09/25

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Basic information
Public title Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Acronym Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Scientific Title Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Scientific Title:Acronym Japan Prevention Trial of Diabetes by Pitavastatin in Patients With Impaired Glucose Tolerance (J-PREDICT)
Region
Japan

Condition
Condition Diabetes mellitus
Classification by specialty
Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the effects of pitavastatin for preventing diabetes in a population with impaired glucose tolerance (IGT).
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Cumulative incidence of diabetes based on 1 positive OGTT or fasting glucose levels
Key secondary outcomes Cumulative incidence of diabetes based on clinical diagnosis defined as at least one of the following:(1) Typical symptoms of diabetes 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.
The classification and diagnostic criteria of diabetes mellitus have been defined by Japan Diabetes. Society(Diabetes Vol.53,No.6,2010)
; Development of diabetes based on 1 positive OGTT or fasting glucose levels
; New development of diabetes based on 2 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)
; Incidence of newly developed diabetes
; 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, subarachnoid hemorrhage, transient ischemic attack, arteriosclerosis obliterans, leg amputation, endovascular or surgical intervention in leg arteries, sudden death); 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-OHdG; Fasting plasma glucose; 2-h plasma glucose during 75g oral glucose tolerance test; HbA1c; Insulin; HOMA-R; HOMA-beta; Insulinogenic index
; Time until dropout
; Number of adverse events

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 Group with life-style intervention alone:
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
Interventions/Control_2 Group with life-style interventions plus concomitant use of pitavastatin: once-daily dosing of pitavastatin 1 mg (1 tablet of Livalo Tab 1 mg), or 2 mg (2 tablets of Livalo Tab 1 mg or 1 tablet of Livalo Tab 2 mg); Dosing period of pitavastatin should be 60 months (max. 84 months).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
30 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria [1] Inclusion Criteria for the screening test (within 6 months before screening)
- Men and women
- Age 30-74
- 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:
a) Second degree relative with diabetes
b) BMI >= 24 kg/m2
c) Systolic blood pressure >=130 mmHg, and/or diastolic blood pressure >= 85 mmHg, and/or receiving treatment for hypertension
d) 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
[2] Inclusion Criteria for the entry; Confirmed by the 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)
Key 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, pheochromocytome, 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 DB` >= 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 stury period
-Contraindication or relative contraindication of Livalo Tab (pitavastatin calcium)
a) History of hypersensitivity to any of the ingredients of the product
b) Severe hepatic disorder or biliary atresia
c) Receiving cyclosporine
d) Pregnant women, women suspected of being pregnant, or lactating women
e) 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
Target sample size 1240

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Kadowaki
Organization Graduate School of Medicine, the University of Tokyo
Division name Department of Metabolic Diseases
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-8815
Email kadowaki-dm@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Yamazaki
Organization Graduate School of Medicine, the University of Tokyo
Division name Clinical Bioinformatics Study Unit
Zip code
Address 7-3-1 Hongo Bunkyo-ku, Tokyo 113-8655, Japan
TEL 03-5800-9844
Homepage URL
Email yama-tky@umin.ac.jp

Sponsor
Institute Graduate School of Medicine, the University of Tokyo
Institute
Department

Funding Source
Organization The Waksman Foundation of Japan
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 NCT00301392
Org. issuing International ID_1 ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 28 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results J-PREDICT
ADA 73rd Scientific Sessions (2013)
Session: Late Breaking Abstracts
Abstract Number: 61-LB
Title: Pitavastatin for the Delay or Prevention of Diabetes Development in Individuals with Impaired Glucose Tolerance
Abstract: Of 8,472 patients who underwent screening, 1,269 individuals with impaired glucose tolerance (IGT) were randomized to either the pitavastatin group (lifestyle modification and pitavastatin [1-2 mg/day]) or the control group (lifestyle modification only).
The diabetes incidence rates for the pitavastatin and control groups were 163 and 186 cases per 1,000 person-years, respectively; the hazard ratio for progression from IGT to diabetes in the pitavastatin group was 0.82 (95% CI: 0.68-0.99; P = 0.041). Even in any subgroups, pitavastatin did not accelerate the incidence, unlike the effects of statins in previous reports. Pitavastatin in combination with lifestyle modification was associated with a lower incidence of diabetes than was lifestyle modification alone in Japanese patients with IGT. Statins are now used with the understanding that a slightly increased risk of diabetes is outweighed by cardiovascular benefits of the drugs. However, based on our results, it may be necessary to reconsider whether all statins really increase the risk of developing diabetes.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2006 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2006 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 Month 31 Day
Date of closure to data entry
2012 Year 06 Month 28 Day
Date trial data considered complete
2012 Year 10 Month 03 Day
Date analysis concluded
2012 Year 10 Month 13 Day

Other
Other related information

Management information
Registered date
2013 Year 11 Month 28 Day
Last modified on
2018 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014547

Research Plan
Registered date File name
2013/11/28 実施計画書 ver.6.0.doc

Research case data specifications
Registered date File name
2013/11/28 J-PREDICT_解析用データセット仕様書_v2.0.zip

Research case data
Registered date File name
2013/11/28 DS.zip


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