Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.continuous subcutaneous insulin infusion combined with rosiglitazone 3.continuous subcutaneous insulin infusion combined with metformin,4.continuous subcutaneous insulin infusion combined with α- thioctic acid daily injections,) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

Official Title
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Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: CSII,ALA,MET,RSG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: newly diagnosed type 2 diabetes, Exclusion Criteria: received previous antihyperglycaemic therapy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 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 |
| --- | --- |
| Active Comparator: CSII<br>CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along. | Drug: CSII,ALA,MET,RSG<br>* CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.<br>|
| Active Comparator: ALA<br>ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. | Drug: CSII,ALA,MET,RSG<br>* CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.<br>|
| Active Comparator: RSG<br>RSG:CSII combined with three months rosiglitazoneor 4mg QD. | Drug: CSII,ALA,MET,RSG<br>* CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.<br>|
| Active Comparator: MET<br>MET:CSII combined with metformin 500mg BID-TID. | Drug: CSII,ALA,MET,RSG<br>* CSII along.ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD. RSG:CSII combined with three months rosiglitazoneor 4mg QD. MET:CSII combined with metformin 500mg BID-TID.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| beta cell function;fast blood glucose; |  | 2011/05 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,, α-lipoic acid ,rosiglitazone ,metformin，therapy