- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01574508
Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)
3. mai 2013 oppdatert av: Guang Ning, Shanghai Jiao Tong University School of Medicine
The current study will compare the different efficacy of two transient intensive insulin treatment strategies: Continuous subcutaneous insulin infusion (CSII) and multiple daily insulin injections (MDI) in patients who are not well controlled with oral hypoglycaemic agents.
Studieoversikt
Status
Ukjent
Forhold
Studietype
Intervensjonell
Registrering (Forventet)
120
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Shanghai
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Shanghai, Shanghai, Kina, 200025
- Rekruttering
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
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Ta kontakt med:
- Guang Ning, Professor
- Telefonnummer: 665344 8621-64370045
- E-post: feifei1116@hotmail.com
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Hovedetterforsker:
- Guang Ning, Professor
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
25 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Using at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose); or at least two kinds of oral hypoglycaemic agents, one of which must be insulin secretagogues (at least half of the maximum permitted daily dose), plus once daily basic insulin treatment (daily dosage < 30IU);
- The anti-diabetic therapy is stable within 3 months before study screening;
- Age: 25-65years, both gender, BMI: 20-35kg/m2;
- Good compliance with the follow-up
- Signed informed consent
- HbA1c ≥ 8.0 % and ≤ 12%
Exclusion Criteria:
- Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
- For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
- Having the history of using GLP-1 for therapy within 3 months before screening
- Women in pregnancy or under breast feeding
- Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
- Allergic to study drugs
- Severe liver dysfunction, including serum alanine aminotransferase concentration more than 2.5 times above upper limit of normal range, abnormal renal function (GFR < 60ml/min)
- Other severe conditions which will put the patients in high risk during the study
- Recently drug or alcohol abuse
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Continuous Subcutaneous Insulin Infusion
CSII
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Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital.
The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.
Andre navn:
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Aktiv komparator: Multiple Daily Insulin Injections
MDI
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Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital.
The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Glycated hemoglobin levels
Tidsramme: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated hemoglobin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
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During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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Glycated albumin levels
Tidsramme: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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The different influence of two intensive insulin treatment strategies: CSII and MDI on the change of glycated albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
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During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
The glucose levels
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Episode of hypoglycemia
Tidsramme: During 2 weeks of intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment
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During 2 weeks of intensive treatment and 1 year after treatment
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Body weight
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Biochemical parameters and inflammatory factors
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of biochemical parameters and inflammatory factors during 2 weeks intensive treatment and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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C peptide levels
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The different influence of CSII and MDI on the change of C peptide levels during 2 weeks intensive treatment period and 1 year after treatment
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During 2 weeks intensive treatment and 1 year after treatment
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Number of participants with adverse events
Tidsramme: During 2 weeks intensive treatment and 1 year after treatment
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The number of Participants with adverse events in different intensive treatment strategies (CSII or MDI) during 2 weeks intensive treatment period and 1 year after treatment.
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During 2 weeks intensive treatment and 1 year after treatment
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2011
Primær fullføring (Forventet)
1. desember 2013
Studiet fullført (Forventet)
1. desember 2014
Datoer for studieregistrering
Først innsendt
25. januar 2012
Først innsendt som oppfylte QC-kriteriene
8. april 2012
Først lagt ut (Anslag)
10. april 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
6. mai 2013
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. mai 2013
Sist bekreftet
1. mai 2013
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CCEMD012
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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