Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
Overview
- Phase
- Phase 4
- Intervention
- Dapagliflozin 10 MG
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
- Enrollment
- 100
- Primary Endpoint
- the effect of dapagliflozin combined with CSII on glucose profile
- Last Updated
- 6 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Dapagliflozin combined with CSII
Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.
Intervention: Dapagliflozin 10 MG
CSII alone
Aspart infused by CSII alone as glucose lowering therapy.
Intervention: Insulin Aspart
Outcomes
Primary Outcomes
the effect of dapagliflozin combined with CSII on glucose profile
Time Frame: 5 weeks
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 Outcomes
- the effects of dapagliflozin combined with CSII on blood pressure(5 weeks)
- the effects of dapagliflozin combined with CSII on weight(5 weeks)
- the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)(5 weeks)