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

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.

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: Transient Continuous Subcutaneous Insulin Infusion; Drug: Transient Multiple Daily Insulin Injections

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
      • Contact: Guang Ning, Professor; Phone Number: 665344 8621-64370045; Email: feifei1116@hotmail.com
      • Principal Investigator: Guang Ning, Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: MDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: January 25, 2012
• First Submitted That Met QC Criteria: April 8, 2012
• First Posted (Estimate): April 10, 2012

Study Record Updates

• Last Update Posted (Estimate): May 6, 2013
• Last Update Submitted That Met QC Criteria: May 3, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: safety; efficacy; intensive insulin therapy
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: CCEMD012