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>=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 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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name