- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01574508
Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)
3 maj 2013 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Studietyp
Interventionell
Inskrivning (Förväntat)
120
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200025
- Rekrytering
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
-
Kontakt:
- Guang Ning, Professor
- Telefonnummer: 665344 8621-64370045
- E-post: feifei1116@hotmail.com
-
Huvudutredare:
- Guang Ning, Professor
-
-
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
25 år till 65 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Continuous Subcutaneous Insulin Infusion
CSII
|
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.
Andra namn:
|
Aktiv komparator: Multiple Daily Insulin Injections
MDI
|
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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Glycated hemoglobin levels
Tidsram: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
|
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.
|
During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
|
Glycated albumin levels
Tidsram: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
|
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.
|
During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
The glucose levels
Tidsram: During 2 weeks intensive treatment and 1 year after treatment
|
The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment
|
During 2 weeks intensive treatment and 1 year after treatment
|
Episode of hypoglycemia
Tidsram: During 2 weeks of intensive treatment and 1 year after treatment
|
The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment
|
During 2 weeks of intensive treatment and 1 year after treatment
|
Body weight
Tidsram: During 2 weeks intensive treatment and 1 year after treatment
|
The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment
|
During 2 weeks intensive treatment and 1 year after treatment
|
Biochemical parameters and inflammatory factors
Tidsram: During 2 weeks intensive treatment and 1 year after treatment
|
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
|
During 2 weeks intensive treatment and 1 year after treatment
|
C peptide levels
Tidsram: During 2 weeks intensive treatment and 1 year after treatment
|
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
|
During 2 weeks intensive treatment and 1 year after treatment
|
Number of participants with adverse events
Tidsram: During 2 weeks intensive treatment and 1 year after treatment
|
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.
|
During 2 weeks intensive treatment and 1 year after treatment
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
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 december 2011
Primärt slutförande (Förväntat)
1 december 2013
Avslutad studie (Förväntat)
1 december 2014
Studieregistreringsdatum
Först inskickad
25 januari 2012
Först inskickad som uppfyllde QC-kriterierna
8 april 2012
Första postat (Uppskatta)
10 april 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
6 maj 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 maj 2013
Senast verifierad
1 maj 2013
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CCEMD012
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Diabetes typ 2
-
Bnai Zion Medical CenterOkänd
-
Jiangsu HengRui Medicine Co., Ltd.Avslutad
-
Mathias Ried-LarsenAvslutadDiabetes mellitus, typ 2 | Typ 2-diabetes mellitus | Diabetes typ 2 | Typ 2 diabetes mellitusDanmark
-
Shanghai HEP Pharmaceutical Co., Ltd.Indragen
-
Jeil Pharmaceutical Co., Ltd.Har inte rekryterat ännuTyp 2-diabetes mellitusKorea, Republiken av
-
Nanjing First Hospital, Nanjing Medical UniversityRekrytering
-
Sun Yat-sen UniversityGuangdong Provincial Hospital of Traditional Chinese Medicine; The Third... och andra samarbetspartnersRekrytering
-
BayerAktiv, inte rekryterande
-
Nanjing First Hospital, Nanjing Medical UniversityAktiv, inte rekryterandeTyp 2-diabetes mellitusKina
Kliniska prövningar på Transient Continuous Subcutaneous Insulin Infusion
-
Pacific Diabetes TechnologiesRekrytering
-
Gianna WilkieAvslutadTyp 1-diabetes | Graviditet, hög riskFörenta staterna
-
University of AarhusAvslutad
-
Fuzhou General HospitalAvslutad
-
Rush University Medical CenterAvslutadDiabetesFörenta staterna
-
Central South UniversityAvslutadLevertransplantationKina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...AvslutadDiabetes mellitus typ IINederländerna
-
Centre Hospitalier Universitaire DijonOkänd
-
University at BuffaloAmerican Diabetes AssociationAvslutad
-
Wanpen VongpatanasinIndragen