NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000949

Registered date:16/12/2007

Nippon ultra-rapid insulin and diabetic complication evaluation

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedtype2 diabetes mellitus
Date of first enrollment2003/03/01
Target sample size400
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Intensified insulin therapy with ultrarapid insulin-analogue (Ins-Asp) Intensified insulin therapy with human regular insulin

Outcome(s)

Primary OutcomeCardiovascular events 1)Sudden death: Natural death within 24 hours after development of acute symptoms. 2)Brain: New development or recurrence of apoplexy or transient cerebral ischemic attack 3)Heart: New development or recurrence of acute myocardial infarction, and new development, aggravation or recurrence of angina pectoris 4)Newly developed ASO, amputation of leg due to ASO, arteriosclerotic peripheral arterial occlusion (Grade 2 or above of Fontaine Classification)
Secondary Outcome1)Total mortality 2)Changes in the mean IMT of common carotid arteries 3)Changes in the pulse wave velocity (PWV) (rt & 1t baPWV), ABI

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum85years-old
GenderMale and Female
Include criteria
Exclude criteria1) Patients with type1 diabetes mellitus 2) Patients with a past history of cerebral angiopathy (cerebral hemorrhage, cerebral infarction, transient cerebral ischemic attack, subarachnoid hemorrhage, etc.) within 6 months before giving consent 3) Patients with a past history of myocardial infarction within 6 months before giving consent 4) Patients planning to receive PTCA or CABG, or who had PTCA or CABG within 6 months before giving consent 5) Patients with coronary arteriopathy (ischemic heart disease, angina pectoris, etc.) that requires treatment with beta-blocker or calcium-antagonist 6) Patients with atrial fibrillation or atrial flutter 7) Patients with renal dysfunction (serum creatinine >3.0 mg/dL) 8) Patients with liver dysfunction (AST, ALT >100 IU/L) 9) Patients with a past history or suspected of having a malignant tumor within 5 years before giving consent 10) Pregnant or possibly pregnant patients 11)Other patients judged inappropriate for the study by the investigators (patients presenting difficulty in frequently receiving rapid-acting type insulin or ultrarapid-acting type insulin therapy, including patients' compliance with treatment)

Related Information

Contact

public contact
Name Haruo Nishimura
Address 2-10-39, Shibata, Kitaku, Osaka,Japan Japan
Telephone 06-6372-0333
E-mail hnis@kuhp.kyoto-u.ac.jp
Affiliation NICE-study EBM center
scientific contact
Name Haruo Nishimura
Address 2-10-39, Shibata, Kitaku, Osaka,J apan Japan
Telephone 06-6372-0333
E-mail
Affiliation Osaka Saiseikai Nakatsu Hospital Divson of Endosrinology and diabetes