UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000949 |
|---|---|
| Receipt number | R000001139 |
| Scientific Title | Nippon ultra-rapid insulin and diabetic complication evaluation |
| Date of disclosure of the study information | 2007/12/16 |
| Last modified on | 2008/01/05 16:39:14 |
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Basic information
Public title
Nippon ultra-rapid insulin and diabetic complication evaluation
Acronym
NICE-study
Scientific Title
Nippon ultra-rapid insulin and diabetic complication evaluation
Scientific Title:Acronym
NICE-study
Region
| Japan |
Condition
Condition
type2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
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)
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intensified insulin therapy with ultrarapid insulin-analogue (Ins-Asp)
Interventions/Control_2
Intensified insulin therapy with human regular insulin
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key 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.
Key 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)
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruo Nishimura |
Organization
Osaka Saiseikai Nakatsu Hospital
Division name
Divson of Endosrinology and diabetes
Zip code
Address
2-10-39, Shibata, Kitaku, Osaka,J apan
TEL
06-6372-0333
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruo Nishimura |
Organization
NICE-study
Division name
EBM center
Zip code
Address
2-10-39, Shibata, Kitaku, Osaka,Japan
TEL
06-6372-0333
Homepage URL
http://members.at.infoseek.co.jp/tounyo/NICE-study.html
hnis@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
NICE-study EBM center
Institute
Department
Personal name
Funding Source
Organization
2-10-39, Shibata, Kitaku, Osaka,J apan
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-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
Name of secondary funder(s)
NON
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT00575172
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
http://members.at.infoseek.co.jp/tounyo/NICE-study.html
Publication of results
Unpublished
Result
URL related to results and publications
http://members.at.infoseek.co.jp/tounyo/NICE-study.html
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2003 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2008 | Year | 01 | Month | 01 | Day |
Other
Other related information
NON
Management information
Registered date
| 2007 | Year | 12 | Month | 14 | Day |
Last modified on
| 2008 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001139
