NIPH Clinical Trials Search

UMIN ID: UMIN000000846

Registered date:09/10/2007

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

Basic Information

Recruitment status Complete: follow-up continuing
Health condition(s) or Problem(s) studiedType 2 Diabetes
Date of first enrollment2007/09/01
Target sample size500
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Pioglitazone (15-45 mg/day) An oral diabetic drug other than pioglitazone.


Primary OutcomeComposite endpoints: overall death + stroke + myocardial infarction (Kaplan Meier method).
Secondary OutcomeIncidence 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

Key inclusion & exclusion criteria

Age minimum55years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria1 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

Related Information


public contact
Name Munehide Matsuhisa, MD
Address Yamadaoka Suita, Osaka 565-0871 Japan Japan
Telephone 06-6879-3633
Affiliation Osaka University Graduate School of Medicine, Faculty of Medicine Department of Endocrine and Metabolic Internal Mmedicine
scientific contact
Name Ryuzo Kawamori, MD
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan 701-0114 Japan
Telephone 03-3813-3111
Affiliation Juntendo University School of Medicine Division of Metabolism & Endocrinology, Department of Medicine,