Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

Phase 4

• Conditions: Type 2 Diabetes
• Interventions: Drug: Transient Continuous Subcutaneous Insulin Infusion; Drug: Transient Multiple Daily Insulin Injections

• Registration Number: NCT01574508
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-25
• Study First Submitted QC: 2012-04-08
• Study First Posted: 2012-04-10
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-03
• Last Update Posted: 2013-05-06
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Subcutaneous Insulin Infusion	Transient Continuous Subcutaneous Insulin Infusion	CSII
Multiple Daily Insulin Injections	Transient Multiple Daily Insulin Injections	MDI

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin levels	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.
Glycated albumin levels	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

Name	Time	Method
Body weight	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
Biochemical parameters and inflammatory factors	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
C peptide levels	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
Number of participants with adverse events	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.
The glucose levels	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
Episode of hypoglycemia	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

Trial Locations

Locations (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China