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

7 januari 2008 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Diabetes mellitus

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

346

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 85 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått	Tidsram
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 Tidsram: five years	five years

Sekundära resultatmått

Resultatmått	Tidsram
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 Tidsram: five years	five years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Osaka Saiseikai Nakatsu Hospital

Utredare

Studiestol: Hideshi Kuzuya, M.D.,Ph.D, Higasiyama Takeda Hospital
Studierektor: Makoto Otoshi, MD.,Ph.D., Ohtoshi Clinic
Huvudutredare: Haruo Nishimura, MD.,Ph.D., Osaka Saiseikai Nakatsu Hospital
Huvudutredare: Koji Maeda, MD., Maeda Clinic
Huvudutredare: Mitsuyo Shintani, MD.,Ph.D., Osaka Saiseikai Nakatsu Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 mars 2003

Avslutad studie (Faktisk)

1 december 2007

Studieregistreringsdatum

Först inskickad

17 december 2007

Först inskickad som uppfyllde QC-kriterierna