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Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes

Primary Purpose

Type2 Diabetes

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Exenatide or metformin hydrochloride
Sponsored by
Beijing Chao Yang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

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

Inclusion Criteria:

  • age 20 - <65 years,
  • body mass index (BMI) ≥ 24 kg/m2,
  • HbA1c ≥ 7% (53mmol/mol).
  • diabetes antibodies (-)
  • diagnosed with T2D within the previous 3 months

Exclusion Criteria:

  • anti-diabetic drugs or diet therapy before participation
  • pancreatitis
  • coronary artery disease
  • liver function impairment
  • renal function impairment
  • intestinal surgery
  • chronic hypoxic diseases (emphysema and cor pulmonale)
  • infectious disease
  • hematological disease
  • systemic inflammatory disease
  • cancer
  • pregnant, possibly pregnant
  • ingesting agents known to influence glucose or lipid metabolism

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    exenatide group

    metformin group

    Arm Description

    The drug-naïve, overweight or obese patients with newly diagnosed T2D

    The drug-naïve, overweight or obese patients with newly diagnosed T2D

    Outcomes

    Primary Outcome Measures

    The change of HbA1c

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2017
    Last Updated
    September 29, 2017
    Sponsor
    Beijing Chao Yang Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03297879
    Brief Title
    Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes
    Official Title
    Beijing Chao-Yang Hospital, Capital Medical University
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    February 28, 2016 (Actual)
    Study Completion Date
    February 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beijing Chao Yang Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The present study assessed the therapeutic effect of exenatide and metformin as the initial therapy in overweight/obese patients with newly diagnosed Type 2 diabetes (T2D).
    Detailed Description
    The present study was a prospective, nonrandomized, interventional study.The drug-naïve, overweight or obese patients with newly diagnosed T2D were consecutively enrolled. The inclusion criteria: 1) age 20 - <65 years, 2) body mass index (BMI) ≥ 24 kg/m2 [7], and 3) HbA1c ≥ 7% (53mmol/mol). An oral glucose tolerance test was performed during the screenings. All of the patients have no diabetes antibodies and were diagnosed with T2D within the previous 3 months, according to the ADA diagnostic criteria. None of the patients had administered anti-diabetic drugs or diet therapy before participation. Neither of the patients presented any history of pancreatitis, coronary artery disease, liver function impairment, renal function impairment, intestinal surgery, chronic hypoxic diseases (emphysema and cor pulmonale), infectious disease, hematological disease, systemic inflammatory disease, or cancer. Patients who were pregnant, possibly pregnant, or ingesting agents known to influence glucose or lipid metabolism were also excluded.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type2 Diabetes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    230 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    exenatide group
    Arm Type
    Experimental
    Arm Description
    The drug-naïve, overweight or obese patients with newly diagnosed T2D
    Arm Title
    metformin group
    Arm Type
    Active Comparator
    Arm Description
    The drug-naïve, overweight or obese patients with newly diagnosed T2D
    Intervention Type
    Drug
    Intervention Name(s)
    Exenatide or metformin hydrochloride
    Intervention Description
    Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.
    Primary Outcome Measure Information:
    Title
    The change of HbA1c
    Time Frame
    baseline and 12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age 20 - <65 years, body mass index (BMI) ≥ 24 kg/m2, HbA1c ≥ 7% (53mmol/mol). diabetes antibodies (-) diagnosed with T2D within the previous 3 months Exclusion Criteria: anti-diabetic drugs or diet therapy before participation pancreatitis coronary artery disease liver function impairment renal function impairment intestinal surgery chronic hypoxic diseases (emphysema and cor pulmonale) infectious disease hematological disease systemic inflammatory disease cancer pregnant, possibly pregnant ingesting agents known to influence glucose or lipid metabolism

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35432194
    Citation
    Zhang L, Hu Y, An Y, Wang Q, Liu J, Wang G. The Changes of Lipidomic Profiles Reveal Therapeutic Effects of Exenatide in Patients With Type 2 Diabetes. Front Endocrinol (Lausanne). 2022 Mar 31;13:677202. doi: 10.3389/fendo.2022.677202. eCollection 2022.
    Results Reference
    derived
    PubMed Identifier
    29358950
    Citation
    Liu J, Hu Y, Xu Y, Jia Y, Miao L, Wang G. Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients with Newly Diagnosed Type 2 Diabetes. Int J Endocrinol. 2017;2017:9401606. doi: 10.1155/2017/9401606. Epub 2017 Nov 20.
    Results Reference
    derived

    Learn more about this trial

    Comparison of Exenatide and Metformin Monotherapy in Overweight/Obese Patients With Newly Diagnosed Type 2 Diabetes

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