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

Sponsored by:	Osaka Saiseikai Nakatsu Hospital
Information provided by:	Osaka Saiseikai Nakatsu Hospital
ClinicalTrials.gov Identifier:	NCT00575172

Purpose

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.

Condition
Diabetes Mellitus

MedlinePlus related topics: Diabetes Diabetes Complications

Drug Information available for: Insulin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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.

Further study details as provided by Osaka Saiseikai Nakatsu Hospital:

Primary Outcome Measures:

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 Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	346
Study Start Date:	March 2003
Study Completion Date:	December 2007

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

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.

Eligibility

Ages Eligible for Study:	20 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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.

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:

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00575172

Locations

Japan
Osaka Saiseikai Nakatsu Hospital
Osaka, Japan, 503-0012

Sponsors and Collaborators

Osaka Saiseikai Nakatsu Hospital

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

More Information

NICE-study Homepage This link exits the ClinicalTrials.gov site

Responsible Party:	NICE-study EBM center ( Osaka Saiseikai Nakatsu Hospital )
Study ID Numbers:	UMIN0949, UMIN00000949
Study First Received:	December 17, 2007
Last Updated:	January 7, 2008
ClinicalTrials.gov Identifier:	NCT00575172
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Osaka Saiseikai Nakatsu Hospital:

type2 diabetes mellitus
cardiovascular disease
macrovascular event

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy

Metabolic disorder
Glucose Metabolism Disorders
Insulin
Diabetes Complications

ClinicalTrials.gov processed this record on January 16, 2009