UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000846 |
|---|---|
| Receipt number | 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 | 2023/10/25 21:22:51 |
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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>=100µg/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
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
matuhisa@medone.med.osaka-u.ac.jp
Sponsor or person
Institute
PROFIT-J Study Steering Committee
Institute
Department
Personal name
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
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
| 2007 | Year | 06 | Month | 01 | Day |
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
| 2013 | Year | 09 | Month | 12 | Day |
Other
Other related information
This study was published in Journal of Atherosclerosis and Thrombosis (2014; 21: 563-573).
Management information
Registered date
| 2007 | Year | 10 | Month | 09 | Day |
Last modified on
| 2023 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001016
