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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Transient Continuous Subcutaneous Insulin Infusion Drug: Transient Multiple Daily Insulin Injections Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2011
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Continuous Subcutaneous Insulin Infusion
CSII
 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
Active Comparator: Multiple Daily Insulin Injections
MDI
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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.


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01574508


Locations
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China, Shanghai
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: Guang Ning, Professor    8621-64370045 ext 665344    feifei1116@hotmail.com   
Principal Investigator: Guang Ning, Professor         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
More Information
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Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01574508    
Other Study ID Numbers: CCEMD012
First Posted: April 10, 2012    Key Record Dates
Last Update Posted: May 6, 2013
Last Verified: May 2013
Keywords provided by Guang Ning, Shanghai Jiao Tong University School of Medicine:
efficacy
safety
intensive insulin therapy
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs