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

Phase 4

Suspended

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: CSII,ALA,MET,RSG

• Registration Number: NCT00948324
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2009-07-28
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-01
• Last Update Posted: 2017-10-03
• Primary Completion: 2019-05
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• newly diagnosed type 2 diabetes,

Exclusion Criteria

• received previous antihyperglycaemic therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CSII	CSII,ALA,MET,RSG	CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along.
ALA	CSII,ALA,MET,RSG	ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD.
MET	CSII,ALA,MET,RSG	MET:CSII combined with metformin 500mg BID-TID.
RSG	CSII,ALA,MET,RSG	RSG:CSII combined with three months rosiglitazoneor 4mg QD.

Primary Outcome Measures

Name	Time	Method
beta cell function;fast blood glucose;	2011/05