Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
1 other identifier
interventional
400
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 type-2-diabetes-mellitus
Started Jun 2008
Longer than P75 for phase_4 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 28, 2009
CompletedFirst Posted
Study publicly available on registry
July 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 3, 2017
October 1, 2017
10.9 years
July 28, 2009
October 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
beta cell function;fast blood glucose;
2011/05
Study Arms (4)
CSII
ACTIVE COMPARATORCSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along.
ALA
ACTIVE COMPARATORALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD.
RSG
ACTIVE COMPARATORRSG:CSII combined with three months rosiglitazoneor 4mg QD.
MET
ACTIVE COMPARATORMET:CSII combined with metformin 500mg BID-TID.
Interventions
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 Criteria
You may qualify if:
- newly diagnosed type 2 diabetes,
You may not qualify if:
- received previous antihyperglycaemic therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Liu L, Ke W, Wan X, Zhang P, Cao X, Deng W, Li Y. Insulin requirement profiles of short-term intensive insulin therapy in patients with newly diagnosed type 2 diabetes and its association with long-term glycemic remission. Diabetes Res Clin Pract. 2015 May;108(2):250-7. doi: 10.1016/j.diabres.2015.02.011. Epub 2015 Feb 21.
PMID: 25765670DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Li Yan Bing, MD
Ministry of Education
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Endocrinology and Diabetes Center, The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong, P. R. China
Study Record Dates
First Submitted
July 28, 2009
First Posted
July 29, 2009
Study Start
June 1, 2008
Primary Completion
May 1, 2019
Study Completion
December 1, 2021
Last Updated
October 3, 2017
Record last verified: 2017-10