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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000846
Receipt No. R000001016
Scientific Title Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction
Date of disclosure of the study information 2007/10/09
Last modified on 2011/11/09

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Basic information
Public title Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction
Acronym Primary prevention for high risk Type 2 Diabetes patients in Japan:PROFIT-J
Scientific Title Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction
Scientific Title:Acronym Primary prevention for high risk Type 2 Diabetes patients in Japan:PROFIT-J
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is designed to examine whether treatment with an oral antidiabetic agent will prevent cerebrovascular and cardiovascular events in patients with type 2 diabetes who are defined as being at high risk for cerebral infarction.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endpoints: overall death + stroke + myocardial infarction (Kaplan Meier method).
Key secondary outcomes Incidence of cerebral infarction (Kaplan Meier method)
Incidence of cerebral infarction + TIA
Incidence of cardiovascular events (myocardial infarction + angina + PCI/CABG)
Incidence of acute coronary syndromes
Albuminuria (absolute value and progression determined according to the stage of nephropathy)
Cerebrovascular events categorized as ischemic or vascular and specific disease: secondary endpoint
Index related to blood glucose: HbA1c
Blood pressure: SBP and DBP
Serum lipids: LDL, HDL, TG
Cognitive function and depression: MMSE, Hasegawa Dementia Scale Revised (HDSR)
Japan Stroke Scale - Depression Scale (JSS-D) only in institutes that can give this test
Safety: hypoglycemia, edema, heart failure, liver function

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pioglitazone (15-45 mg/day)
Interventions/Control_2 An oral diabetic drug other than pioglitazone.
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
55 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria Patients diagnosed as having type 2 diabetes and whosatisfy one of the following criteria
1 Asymptomatic cerebral infarction evident on MRI.
2 Mean IMT=>1mm (far wall, either right or left)
3 Albuminuria>=100&micro;g/mg creatinine (spot urine sample)
HbA1C<=10%
Concomitant hypertension or hyperlipidemia
Key exclusion criteria 1 Current or past history of heart failure
2 History of treatment with a thiazolidine derivative within 8 weeks
3 Severe liver dysfunction:ALT>=
100 or viral hepatitis
4 Severe renal dysfunction:Cr>=2.5
5 Concerns about safety of a thiazolidine derivative
6 Concerns about safety of drugs to be studied
7 Cerebral hemorrhage
8 Manifest dementia
9 History of documented myocardial infarction or angina prior to registration
10 Those whom the principle investigators or other investigators consider unsuitable
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuzo Kawamori, MD
Organization Juntendo University School of Medicine
Division name Division of Metabolism & Endocrinology, Department of Medicine,
Zip code
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan 701-0114
TEL 03-3813-3111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Munehide Matsuhisa, MD
Organization Osaka University Graduate School of Medicine, Faculty of Medicine
Division name Department of Endocrine and Metabolic Internal Mmedicine
Zip code
Address Yamadaoka Suita, Osaka 565-0871 Japan
TEL 06-6879-3633
Homepage URL
Email matuhisa@medone.med.osaka-u.ac.jp

Sponsor
Institute PROFIT-J Study Steering Committee
Institute
Department

Funding Source
Organization Japan Cardiovascular Research Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 10 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2007 Year 07 Month 23 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2013 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2007 Year 10 Month 09 Day
Last modified on
2011 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001016

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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