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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Guang Ning, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01574508
First received: January 25, 2012
Last updated: May 3, 2013
Last verified: May 2013

January 25, 2012
May 3, 2013
December 2011
December 2013   (final data collection date for primary outcome measure)
  • Glycated hemoglobin levels [ Time Frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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.
Glycated hemoglobin and albumin levels [ Time Frame: During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment. ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT01574508 on ClinicalTrials.gov Archive Site
  • The glucose levels [ Time Frame: During 2 weeks intensive treatment and 1 year after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
Same as current
Not Provided
Not Provided
 
Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy
Not Provided

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 2 Diabetes
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
25 Years to 65 Years
No
China
 
NCT01574508
CCEMD012
Not Provided
Guang Ning, Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
Not Provided
Not Provided
Shanghai Jiao Tong University School of Medicine
May 2013

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