ippon ultra-rapid insulin and diabetic complication evaluatio

Phase 4

• Conditions: type2 diabetes mellitus

• Registration Number: JPRN-UMIN000000949
• Lead Sponsor: ICE-study EBM center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2007-12-01
• Study Start: 2007-12-16
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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