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SuspendedNCT00948324Updated Oct 3, 2017

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

A Phase 4 interventional study of CSII,ALA,MET,RSG in Type 2 Diabetes Mellitus, sponsored by Sun Yat-sen University. Suspended. Open to participants aged 25 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-10-03.

Sponsored by Sun Yat-sen University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
25 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,
  • α-lipoic acid ,rosiglitazone ,metformin,therapy
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's planned enrollment of 400 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • newly diagnosed type 2 diabetes,

Exclusion criteria

Exclusion Criteria:

  • received previous antihyperglycaemic therapy
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants (estimated)

Study arms

  • Active comparator
    CSII

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

    Drug: CSII,ALA,MET,RSG

  • Active comparator
    ALA

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

    Drug: CSII,ALA,MET,RSG

  • Active comparator
    RSG

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

    Drug: CSII,ALA,MET,RSG

  • Active comparator
    MET

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

    Drug: CSII,ALA,MET,RSG

Interventions

  • DrugCSII,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.

06

What researchers measure

Primary outcomes

  1. beta cell function;fast blood glucose;

    Time frame: 2011/05

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 25765670 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00948324
Lead sponsor
Sun Yat-sen University
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) — Principal investigator
First posted
Jul 29, 2009
Start date
Jun 2008
Primary completion
May 2019 (estimated)
Completion
Dec 2021 (estimated)
Last update
Oct 3, 2017

Study contacts

Li Yan Bing, MD
principal investigator · Ministry of Education

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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