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Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)

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ClinicalTrials.gov Identifier: NCT01574508
Recruitment Status : Unknown
Verified May 2013 by Guang Ning, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : April 10, 2012
Last Update Posted : May 6, 2013
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine

Tracking Information
First Submitted Date  ICMJE January 25, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date May 6, 2013
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2012)
  • Glycated hemoglobin levels [ Time Frame: 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.
  • Glycated albumin levels [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
Glycated hemoglobin and albumin levels [ Time Frame: 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 and albumin levels during two weeks intensive insulin treatment period and 1 year after the intensive treatment.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2012)
  • The glucose levels [ Time Frame: 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
  • Episode of hypoglycemia [ Time Frame: 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
  • Body weight [ Time Frame: 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
  • Biochemical parameters and inflammatory factors [ Time Frame: 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
  • C peptide levels [ Time Frame: 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
  • Number of participants with adverse events [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
Official Title  ICMJE Not Provided
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE
  • Drug: Transient Continuous Subcutaneous Insulin Infusion
    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.
    Other Name: CSII
  • Drug: Transient Multiple Daily Insulin Injections
    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
    Other Name: MDI
Study Arms  ICMJE
  • Experimental: Continuous Subcutaneous Insulin Infusion
    CSII
    Intervention: Drug: Transient Continuous Subcutaneous Insulin Infusion
  • Active Comparator: Multiple Daily Insulin Injections
    MDI
    Intervention: Drug: Transient Multiple Daily Insulin Injections
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 8, 2012)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2014
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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);
  2. The anti-diabetic therapy is stable within 3 months before study screening;
  3. Age: 25-65years, both gender, BMI: 20-35kg/m2;
  4. Good compliance with the follow-up
  5. Signed informed consent
  6. HbA1c ≥ 8.0 % and ≤ 12%

Exclusion Criteria:

  1. Having the history of using insulin therapy twice daily or MDI or insulin pump (except the insulin therapy during gestational diabetes mellitus)
  2. For once daily insulin therapy: daily dose insulin therapy dosage > 30IU
  3. Having the history of using GLP-1 for therapy within 3 months before screening
  4. Women in pregnancy or under breast feeding
  5. Having acute diabetic complications within 6 months before screening or having severe chronic diabetic complications at screening
  6. Allergic to study drugs
  7. 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)
  8. Other severe conditions which will put the patients in high risk during the study
  9. Recently drug or alcohol abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01574508
Other Study ID Numbers  ICMJE CCEMD012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Guang Ning, Shanghai Jiao Tong University School of Medicine
Study Sponsor  ICMJE Shanghai Jiao Tong University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai Jiao Tong University School of Medicine
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP