Continuous Subcutaneous Insulin Infusion strAtegy Versus Multiple Daily Insulin Injections strAtegy

Study Overview
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Brief Summary
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: Transient Continuous Subcutaneous Insulin Infusion
* Drug: Transient Multiple Daily Insulin Injections


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Subcutaneous Insulin Infusion<br>CSII | Drug: Transient Continuous Subcutaneous Insulin Infusion<br>* 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.<br>* Other names: CSII;|
| Active Comparator: Multiple Daily Insulin Injections<br>MDI | Drug: Transient Multiple Daily Insulin Injections<br>* 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<br>* Other names: MDI;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety, intensive insulin therapy