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NCT00948324 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data
NCT number NCT00948324
Other study ID # 87755766
Secondary ID
Status Suspended
Phase Phase 4
First received July 28, 2009
Last updated October 1, 2017
Start date June 2008
Est. completion date December 2021

Study information
Verified date October 2017
Source Sun Yat-sen University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Suspended
Enrollment 400
Est. completion date December 2021
Est. primary completion date May 2019
Accepts healthy volunteers No
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria:

- newly diagnosed type 2 diabetes,

Exclusion Criteria:

- received previous antihyperglycaemic therapy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• CSII,ALA,MET,RSG
CSII along.ALA:CSII combined with two weeks a- 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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Sun Yat-sen University

Outcome
Type Measure Description Time frame Safety issue
Primary beta cell function;fast blood glucose; 2011/05
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