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
  Purpose

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 Intervention Phase
Type 2 Diabetes
Drug: Transient Continuous Subcutaneous Insulin Infusion
Drug: Transient Multiple Daily Insulin Injections
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 120
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01574508

Locations
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

No publications provided

Responsible Party: Guang Ning, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01574508     History of Changes
Other Study ID Numbers: CCEMD012
Study First Received: January 25, 2012
Last Updated: May 3, 2013
Health Authority: China: Ethics Committee

Keywords provided by Shanghai Jiao Tong University School of Medicine:
efficacy
safety
intensive insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014