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Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Dapagliflozin 10 MG
Insulin Aspart
Sponsored by
Nanjing First Hospital, Nanjing Medical 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 Continuous Glucose Monitoring System (CGMS), Dapagliflozin, Continuous Subcutaneous Insulin Infusion ( CSII)

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • volunteer to participate and be able to sign informed consent prior to the trial.
  • patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old.
  • No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc.
  • Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise.

Exclusion Criteria:

  • Patients with insulin allergy.
  • Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal.
  • Drug abuse and alcohol dependence in the past 5 years.
  • Systemic hormone therapy was used in the last three months.
  • Patients with poor compliance and irregular diet and exercise.
  • Patients with pregnancy, lactation or pregnancy intention.
  • Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Dapagliflozin combined with CSII

    CSII alone

    Arm Description

    Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.

    Aspart infused by CSII alone as glucose lowering therapy.

    Outcomes

    Primary Outcome Measures

    the effect of dapagliflozin combined with CSII on glucose profile
    To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile(the mean amplitude of glycemic excursions(MAGE),The 24-hrs mean glucose(MG) ) in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system

    Secondary Outcome Measures

    the effects of dapagliflozin combined with CSII on weight
    To compare the effect of dapagliflozin combined with CSII and CSII alone on weight in kilogram
    the effects of dapagliflozin combined with CSII on blood pressure
    To compare the effect of dapagliflozin combined with CSII and CSII alone on blood pressure in mmHg
    the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
    To compare the effect of dapagliflozin combined with CSII and CSII alone on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)

    Full Information

    First Posted
    September 29, 2019
    Last Updated
    October 7, 2019
    Sponsor
    Nanjing First Hospital, Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04120623
    Brief Title
    Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus
    Official Title
    Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2019 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    February 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Nanjing First Hospital, Nanjing Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.
    Detailed Description
    To compare the effect of dapagliflozin combined with continuous subcutaneous insulin infusion (CSII) and CSII alone on glucose profile in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus
    Keywords
    Continuous Glucose Monitoring System (CGMS), Dapagliflozin, Continuous Subcutaneous Insulin Infusion ( CSII)

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Dapagliflozin combined with CSII
    Arm Type
    Experimental
    Arm Description
    Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.
    Arm Title
    CSII alone
    Arm Type
    Active Comparator
    Arm Description
    Aspart infused by CSII alone as glucose lowering therapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Dapagliflozin 10 MG
    Other Intervention Name(s)
    Dapagliflozin combined with CSII
    Intervention Description
    Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
    Intervention Type
    Drug
    Intervention Name(s)
    Insulin Aspart
    Other Intervention Name(s)
    CSII alone
    Intervention Description
    Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)
    Primary Outcome Measure Information:
    Title
    the effect of dapagliflozin combined with CSII on glucose profile
    Description
    To compare the effect of dapagliflozin combined with CSII and CSII alone on glucose profile(the mean amplitude of glycemic excursions(MAGE),The 24-hrs mean glucose(MG) ) in newly diagnosed type 2 diabetes mellitus by continuous glucose monitoring system
    Time Frame
    5 weeks
    Secondary Outcome Measure Information:
    Title
    the effects of dapagliflozin combined with CSII on weight
    Description
    To compare the effect of dapagliflozin combined with CSII and CSII alone on weight in kilogram
    Time Frame
    5 weeks
    Title
    the effects of dapagliflozin combined with CSII on blood pressure
    Description
    To compare the effect of dapagliflozin combined with CSII and CSII alone on blood pressure in mmHg
    Time Frame
    5 weeks
    Title
    the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
    Description
    To compare the effect of dapagliflozin combined with CSII and CSII alone on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
    Time Frame
    5 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: volunteer to participate and be able to sign informed consent prior to the trial. patients with type 2 diabetes or type 1 diabetes, aged 18-80 years old. No acute complications such as diabetic ketoacidosis, diabetic hyperosmolar syndrome, etc. Subjects are able and willing to monitor peripheral blood sugar and regularity of diet and exercise. Exclusion Criteria: Patients with insulin allergy. Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value; Serum creatinine was 1.3 times higher than the upper limit of normal. Drug abuse and alcohol dependence in the past 5 years. Systemic hormone therapy was used in the last three months. Patients with poor compliance and irregular diet and exercise. Patients with pregnancy, lactation or pregnancy intention. Any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jianhua Ma, Doctor
    Phone
    8625-52887091
    Ext
    +8618951670116
    Email
    majianhua196503@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jianhua Ma
    Organizational Affiliation
    Nanjing First Hospital, Affiliated to Nanjing Medical University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus

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