type2 diabetes mellitus
Conditions
Interventions
Intensified insulin therapy with ultrarapid insulin-analogue (Ins-Asp)
Intensified insulin therapy with human regular insulin
Sponsors
NICE-study EBM center
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
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are patients satisfying the following conditions 1) – 3). 1)Outpatients and inpatients aged 20 years or more but younger than 85 years. Men or women. 2)Patients with type 2 diabetes based on the diagnostic standard of the Japanese Diabetes Society/American Diabetes Association 3)No specific restriction on the current treatment. Patients having switched treatment are also accepted.
Exclusion criteria
Exclusion 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHaruo Nishimura
NICE-study EBM center
Outcome results
None listed