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
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
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
NCT ID
NCT04120623
First Posted
September 29, 2019
Last Updated
October 7, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
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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