Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

Type 2 Diabetes Clinical Trial

— CAMACS  

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01574508
• Other study ID #: CCEMD012
• Status: Recruiting
• Phase: Phase 4
• First received: January 25, 2012
• Last updated: May 3, 2013
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: May 2013
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

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.
• 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

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiao-Tong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin levels	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.	During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.	No
Primary	Glycated albumin levels	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.	During 2 weeks intensive insulin treatment period and 1 year after the intensive treatment.	No
Secondary	The glucose levels	The different influence of CSII and MDI on the change of plasma glucose levels during 2 weeks intensive treatment and 1 year after treatment	During 2 weeks intensive treatment and 1 year after treatment	No
Secondary	Episode of hypoglycemia	The different influence of CSII and MDI on Episode of hypoglycemia during 2 weeks of intensive treatment and 1 year after treatment	During 2 weeks of intensive treatment and 1 year after treatment	Yes
Secondary	Body weight	The different influence of CSII and MDI on Body weight during 2 weeks intensive treatment and 1 year after treatment	During 2 weeks intensive treatment and 1 year after treatment	No
Secondary	Biochemical parameters and inflammatory factors	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	During 2 weeks intensive treatment and 1 year after treatment	No
Secondary	C peptide levels	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	During 2 weeks intensive treatment and 1 year after treatment	No
Secondary	Number of participants with adverse events	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.	During 2 weeks intensive treatment and 1 year after treatment	Yes