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

This study has suspended participant recruitment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00948324
First Posted: July 29, 2009
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University
  Purpose
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.

Condition Intervention Phase
Type 2 Diabetes Mellitus Drug: CSII,ALA,MET,RSG Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Yanbing Li, Sun Yat-sen University:

Primary Outcome Measures:
  • beta cell function;fast blood glucose; [ Time Frame: 2011/05 ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CSII
CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along.
Drug: CSII,ALA,MET,RSG
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.
Active Comparator: ALA
ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD.
Drug: CSII,ALA,MET,RSG
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.
Active Comparator: RSG
RSG:CSII combined with three months rosiglitazoneor 4mg QD.
Drug: CSII,ALA,MET,RSG
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.
Active Comparator: MET
MET:CSII combined with metformin 500mg BID-TID.
Drug: CSII,ALA,MET,RSG
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed type 2 diabetes,

Exclusion Criteria:

  • received previous antihyperglycaemic therapy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948324


Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Li Yan Bing, MD Ministry of Education
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yanbing Li, Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT00948324     History of Changes
Other Study ID Numbers: 87755766
First Submitted: July 28, 2009
First Posted: July 29, 2009
Last Update Posted: October 3, 2017
Last Verified: October 2017

Keywords provided by Yanbing Li, Sun Yat-sen University:
ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,
α-lipoic acid ,rosiglitazone ,metformin,therapy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs