Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy (CAMACS)
This study is currently recruiting participants.
Verified May 2013 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
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
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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:
- 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
Contacts and Locations
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 Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013