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Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation-Study (NICE-Study)

2008年1月7日更新者：Osaka Saiseikai Nakatsu Hospital

To Investigate Whether the Postprandial Blood Sugar Level as Achieved Using Ultrarapid-Acting Type Insulin Could Prevent Great Vessel Disorder in Japanese Type 2 Diabetic Patients.

For the purpose of comparing efficacy of intensive therapy between 1) ultrarapid-acting type insulin (insulin aspart) and 2) conventional rapid-acting type insulin (R), a Multicenter Open Label Randomized Controlled Trial was planned in Japan using the occurrence of cardiovascular events in patients with diabetes, a high risk factor, as an index.

研究概览

地位

完全的

条件

糖尿病

详细说明

A survey shows that the most frequently observed direct cause of death in diabetic patients is cardiovascular disorder. However, investigations and surveys such as DCCT, UKPDS and KUMAMOTO-study, etc. clarified that strict control of blood sugar level prevented development and progress of diabetic microangiopathy, but could not show a significant effect on great vessel disorder. Recently, the DECODA-study, DECODE-study and Honolulu-study have demonstrated that postprandial high blood sugar is involved in great vessel disorder. Therefore, possible prevention of great vessel disorder in diabetic patients is suggested by improving the postprandial blood sugar level as achieved using ultrarapid-acting type insulin, which has become available recently. Even with results in Europe and the US obtained, the life-style and incidence of complications in Japanese people are different, and there are many points that remain uncertain with respect to the direct application of foreign results to Japanese people. Therefore, in Japan also, it is necessary to conduct a large-scale clinical study and to establish high-level evidence using mainly Japanese people through hospitals having many patients.

研究类型

观察性的

注册 (实际的)

346

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

日本
- - Osaka、日本、503-0012
    - Osaka Saiseikai Nakatsu Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

Japanese outpatients and inpatients aged 20 years or more but younger than 85 years. Men or women. Patients with type 2 diabetes based on the diagnostic standard of the Japanese Diabetes Society/American Diabetes Association. No specific restriction on the current treatment. Patients having switched treatment are also accepted.

描述

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
3. No specific restriction on the current treatment. Patients having switched treatment are also accepted.

Exclusion Criteria:

Patients with type 1 diabetes
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
Patients with a past history of myocardial infarction within 6 months before giving consent
Patients planning to receive PTCA or CABG, or who had PTCA or CABG within 6 months before giving consent
Patients with coronary arteriopathy (angina pectoris, etc.) that requires treatment with β-blocker or calcium-antagonist
Patients with atrial fibrillation or atrial flutter
Patients with renal dysfunction (serum creatinine ≥ 3.0 mg/dL)
Patients with liver dysfunction (AST, ALT ≥ 100 IU/L)
Patients with a past history or suspected of having a malignant tumor within 5 years before giving consent
Pregnant or possibly pregnant patients
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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
U Intensified insulin therapy with ultrarapid insulin-analogue (Insulin-Aspart)
R Intensified insulin therapy with human regular insulin

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Cardiovascular events 1)Sudden death 2)New development or recurrence of apoplexy or TIA 3)New development or recurrence of AMI or and angina pectoris 4)Newly developed ASO, amputation of leg due to ASO 大体时间：five years	five years

次要结果测量

结果测量	大体时间
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 大体时间：five years	five years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Osaka Saiseikai Nakatsu Hospital

调查人员

学习椅：Hideshi Kuzuya, M.D.,Ph.D、Higasiyama Takeda Hospital
研究主任：Makoto Otoshi, MD.,Ph.D.、Ohtoshi Clinic
首席研究员：Haruo Nishimura, MD.,Ph.D.、Osaka Saiseikai Nakatsu Hospital
首席研究员：Koji Maeda, MD.、Maeda Clinic
首席研究员：Mitsuyo Shintani, MD.,Ph.D.、Osaka Saiseikai Nakatsu Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

Nishimura H, Shintani M, Kouji M and Nice-study group J Saiseikai Nakatsu Hospital, 20, 216-220, 2003

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2003年3月1日

研究完成 (实际的)

2007年12月1日

研究注册日期

首次提交

2007年12月17日

首先提交符合 QC 标准的