Nippon ultra-rapid insulin and diabetic complication evaluation

UMIN ID: UMIN000000949

Registered date:16/12/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: type2 diabetes mellitus
• Date of first enrollment: 2003/03/01
• Target sample size: 400
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intensified insulin therapy with ultrarapid insulin-analogue (Ins-Asp)
Intensified insulin therapy with human regular insulin

Outcome(s)

• Primary Outcome: Cardiovascular 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 Outcome: 1)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 minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude criteria: 1) 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

• Primary Sponsor: NICE-study EBM center
• Secondary Sponsor: Kyoto National Hosp, Yodogawa Christ Hosp, Otoshi clinic, Okuda clinic Fukuda clinic,Kishiwada City Hos, Komatsu Hosp, Maeda Clinic, Wakayama Red Cross Med Ctr, Osaka saiseikai Nakatsu Hosp
• Source(s) of Monetary Support: 2-10-39, Shibata, Kitaku, Osaka,J apan,NON
• Secondary ID(s): NCT00575172