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

Sun Yat-sen University

Status and phase: Suspended; Phase 4

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: CSII,ALA,MET,RSG

Study type: Interventional

Funder types: Other

Identifiers

NCT00948324

87755766

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• newly diagnosed type 2 diabetes,

Exclusion criteria

• received previous antihyperglycaemic therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 4 patient groups

CSII

Active Comparator group

Description:

CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along.

Treatment:

Drug: CSII,ALA,MET,RSG

ALA

Active Comparator group

Description:

ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD.

Treatment:

Drug: CSII,ALA,MET,RSG

RSG

Active Comparator group

Description:

RSG:CSII combined with three months rosiglitazoneor 4mg QD.

Treatment:

Drug: CSII,ALA,MET,RSG

MET

Active Comparator group

Description:

MET:CSII combined with metformin 500mg BID-TID.

Treatment:

Drug: CSII,ALA,MET,RSG