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

This study has been completed.
Information provided by Osaka Saiseikai Nakatsu Hospital

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Descriptive Information Fields
Brief Title  Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation-Study (NICE-Study)
Official Title  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.
Brief Summary

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.

Detailed Description

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.

Study Phase
Study Type  Observational
Study Design  Cohort, Prospective
Primary Outcome Measure  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 [ Time Frame: five years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure  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 [ Time Frame: five years ] [ Designated as safety issue: Yes ]
Condition  Diabetes Mellitus
Intervention 
MEDLINE PMIDs
Links NICE-study Homepage This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  346
Start Date  March 2003
Completion Date December 2007
Eligibility 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
    3. No specific restriction on the current treatment. Patients having switched treatment are also accepted.

Exclusion Criteria:

  1. Patients with type 1 diabetes
  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 (angina pectoris, etc.) that requires treatment with β-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)
Gender Both
Ages 20 Years to 85 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  Japan
Administrative Information Fields
NCT ID  NCT00575172
Organization ID UMIN0949
Secondary IDs †† UMIN00000949
Study Sponsor  Osaka Saiseikai Nakatsu Hospital
Collaborators ††
Investigators 
Study Chair:     Hideshi Kuzuya, M.D.,Ph.D     Higasiyama Takeda Hospital    
Study Director:     Makoto Otoshi, MD.,Ph.D.     Ohtoshi Clinic    
Principal Investigator:     Haruo Nishimura, MD.,Ph.D.     Osaka Saiseikai Nakatsu Hospital    
Principal Investigator:     Koji Maeda, MD.     Maeda Clinic    
Principal Investigator:     Mitsuyo Shintani, MD.,Ph.D.     Osaka Saiseikai Nakatsu Hospital    
Information Provided By Osaka Saiseikai Nakatsu Hospital
Verification Date December 2007
First Received Date  December 17, 2007
Last Updated Date January 7, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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