Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction

Primary prevention of cerebrovascular and cardiovascular events with an oral antidiabetic agent in patients with type 2 diabetes at high risk for cerebral infarction - Primary prevention for high risk Type 2 Diabetes patients in Japan:PROFIT-J

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000846

Enrollment

500

Registered

2007-10-09

Start date

2007-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Interventions

Pioglitazone (15-45 mg/day) An oral diabetic drug other than pioglitazone.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Composite endpoints: overall death + stroke + myocardial infarction (Kaplan Meier method).	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMunehide Matsuhisa, MD

Osaka University Graduate School of Medicine, Faculty of Medicine Department of Endocrine and Metabolic Internal Mmedicine

matuhisa@medone.med.osaka-u.ac.jp06-6879-3633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026