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Effects of Different Early Intensive Therapies on Long-term β-cell Function

Primary Purpose

Diabetes Mellitus, Type 2

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CSII
CSII, Metformin, Pioglitazone
CSII, Sitagliptin
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • newly diagnosed type 2 diabetes
  • fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
  • body mass index (BMI) ranging from20～35kg/m2
  • Antihyperglycaemic and antihyperlipidemic medication-naive patients

Exclusion Criteria:

  • having any severe acute or chronic diabetic complications
  • renal dysfunction, blood creatinine≥150µmol/L
  • blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT)
  • • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months
  • chronic or acute pancreatic disease
  • severe systematic diseases or malignant tumor
  • female patients incline to be pregnant
  • being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
  • poor compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    CSII

    Metformin & Pioglitazone

    Sitagliptin

    Arm Description

    continuous subcutaneous insulin infusion

    CSII combined with metformin and pioglitazone

    CSII combined with sitagliptin 100mg/d

    Outcomes

    Primary Outcome Measures

    glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients
    the improvement of β-cell function after short intensive therapy in newly diagnosed type 2 diabetic patients
    the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients

    Secondary Outcome Measures

    the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients
    the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients
    the effects of different interventions on the remission rate in newly-diagnosed type 2 diabetic patients

    Full Information

    First Posted
    November 8, 2011
    Last Updated
    April 8, 2013
    Sponsor
    Sun Yat-sen University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01471808
    Brief Title
    Effects of Different Early Intensive Therapies on Long-term β-cell Function
    Official Title
    Effects of Oral Hypoglycemic Agents Combined With Short-term CSII on Glycemic Control in Newly-diagnosed Type 2 Diabetic Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    December 2020 (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 oral antihyperglycaemic agents combined with short-term continuous subcutaneous insulin infusion(CSII)(1.CSII alone; 2.metformin and pioglitazone combined with CSII; 3. sitagliptin combined with CSII) on long-term glycemic control and β-cell function 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
    Diabetes Mellitus, Type 2

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    CSII
    Arm Type
    Active Comparator
    Arm Description
    continuous subcutaneous insulin infusion
    Arm Title
    Metformin & Pioglitazone
    Arm Type
    Active Comparator
    Arm Description
    CSII combined with metformin and pioglitazone
    Arm Title
    Sitagliptin
    Arm Type
    Active Comparator
    Arm Description
    CSII combined with sitagliptin 100mg/d
    Intervention Type
    Drug
    Intervention Name(s)
    CSII
    Intervention Description
    continuous subcutaneous insulin infusion for 2~4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    CSII, Metformin, Pioglitazone
    Intervention Description
    CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
    Intervention Type
    Drug
    Intervention Name(s)
    CSII, Sitagliptin
    Intervention Description
    CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months
    Primary Outcome Measure Information:
    Title
    glycemic control after short intensive therapy in newly diagnosed type 2 diabetic patients
    Time Frame
    10 years
    Title
    the improvement of β-cell function after short intensive therapy in newly diagnosed type 2 diabetic patients
    Time Frame
    10 years
    Title
    the remission rate after short intensive therapy in newly diagnosed type 2 diabetic patients
    Time Frame
    10 years
    Secondary Outcome Measure Information:
    Title
    the effects of different interventions on glycemic control in newly-diagnosed type 2 diabetic patients
    Time Frame
    10 years
    Title
    the effects of different interventions on β-cell function in newly-diagnosed type 2 diabetic patients
    Time Frame
    10 years
    Title
    the effects of different interventions on the remission rate in newly-diagnosed type 2 diabetic patients
    Time Frame
    10 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: newly diagnosed type 2 diabetes fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L body mass index (BMI) ranging from20～35kg/m2 Antihyperglycaemic and antihyperlipidemic medication-naive patients Exclusion Criteria: having any severe acute or chronic diabetic complications renal dysfunction, blood creatinine≥150µmol/L blood aminotransferase level rising up(more than 2 times of the upper normal limit of ALT) • Any severe cardiac disease including congestive cardiac failure, unstable angina or myocardial infarct in 12 months chronic or acute pancreatic disease severe systematic diseases or malignant tumor female patients incline to be pregnant being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs poor compliance
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanbin Li, 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

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    Effects of Different Early Intensive Therapies on Long-term β-cell Function

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