- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00575172
Nippon Ultra-Rapid Insulin and Diabetic Complication Evaluation-Study (NICE-Study)
7. januar 2008 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
346
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Osaka, Japan, 503-0012
- Osaka Saiseikai Nakatsu Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
20 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
Inclusion Criteria:
Subjects are patients satisfying the following conditions 1) - 3).
- 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
- 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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U
Intensified insulin therapy with ultrarapid insulin-analogue (Insulin-Aspart)
|
R
Intensified insulin therapy with human regular insulin
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: five years
|
five years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: five years
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five years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Hideshi Kuzuya, M.D.,Ph.D, Higasiyama Takeda Hospital
- Studieleder: Makoto Otoshi, MD.,Ph.D., Ohtoshi Clinic
- Ledende efterforsker: Haruo Nishimura, MD.,Ph.D., Osaka Saiseikai Nakatsu Hospital
- Ledende efterforsker: Koji Maeda, MD., Maeda Clinic
- Ledende efterforsker: Mitsuyo Shintani, MD.,Ph.D., Osaka Saiseikai Nakatsu Hospital
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Nishimura H, Shintani M, Kouji M and Nice-study group J Saiseikai Nakatsu Hospital, 20, 216-220, 2003
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2003
Studieafslutning (Faktiske)
1. december 2007
Datoer for studieregistrering
Først indsendt
17. december 2007
Først indsendt, der opfyldte QC-kriterier
17. december 2007
Først opslået (Skøn)
18. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. januar 2008
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. januar 2008
Sidst verificeret
1. december 2007
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- UMIN0949
- UMIN00000949
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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