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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Yanbing Li, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT00948324
First received: July 28, 2009
Last updated: June 4, 2013
Last verified: June 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Sun Yat-sen University:

Primary Outcome Measures:
  • beta cell function;fast blood glucose; [ Time Frame: 2011/05 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: May 2015 (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

Ages Eligible for Study:   25 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • newly diagnosed type 2 diabetes,

Exclusion Criteria:

  • received previous antihyperglycaemic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948324

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

No publications provided

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
Study First Received: July 28, 2009
Last Updated: June 4, 2013
Health Authority: China: Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 30, 2014