search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Suspended
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CSII,ALA,MET,RSG
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,, α-lipoic acid ,rosiglitazone ,metformin，therapy

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed type 2 diabetes,

Exclusion Criteria:

  • received previous antihyperglycaemic therapy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    CSII

    ALA

    RSG

    MET

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    beta cell function;fast blood glucose;

    Secondary Outcome Measures

    Full Information

    First Posted
    July 28, 2009
    Last Updated
    October 1, 2017
    Sponsor
    Sun Yat-sen University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00948324
    Brief Title
    Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
    Official Title
    Effect of Intensive Therapy Associated With CSII on β-cell Function With Newly Diagnosed Type 2 Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2017
    Overall Recruitment Status
    Suspended
    Study Start Date
    June 2008 (undefined)
    Primary Completion Date
    May 2019 (Anticipated)
    Study Completion Date
    December 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sun Yat-sen University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    ype 2 diabetes mellitus, continuous subcutaneous insulin infusion,, α-lipoic acid ,rosiglitazone ,metformin，therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CSII
    Arm Type
    Active Comparator
    Arm Description
    CSII: Patients in continuous subcutaneous insulin infusion group received insulin analogue with an insulin pump along.
    Arm Title
    ALA
    Arm Type
    Active Comparator
    Arm Description
    ALA:CSII combined with two weeks α- thioctic acid (600mg/500ml NaCl, 0.9%), ivdrip QD.
    Arm Title
    RSG
    Arm Type
    Active Comparator
    Arm Description
    RSG:CSII combined with three months rosiglitazoneor 4mg QD.
    Arm Title
    MET
    Arm Type
    Active Comparator
    Arm Description
    MET:CSII combined with metformin 500mg BID-TID.
    Intervention Type
    Drug
    Intervention Name(s)
    CSII,ALA,MET,RSG
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    beta cell function;fast blood glucose;
    Time Frame
    2011/05

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed type 2 diabetes, Exclusion Criteria: received previous antihyperglycaemic therapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Li Yan Bing, MD
    Organizational Affiliation
    Ministry of Education
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25765670
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs