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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Dapagliflozin 10 MG
* Drug: Insulin Aspart


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dapagliflozin combined with CSII<br>Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy. | Drug: Dapagliflozin 10 MG<br>* Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).<br>* Other names: Dapagliflozin combined with CSII;|
| Active Comparator: CSII alone<br>Aspart infused by CSII alone as glucose lowering therapy. | Drug: Insulin Aspart<br>* Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)<br>* Other names: CSII alone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 weeks | 
| 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 | 5 weeks | 
| 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) | 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dapagliflozin, Continuous Glucose Monitoring System (CGMS), Continuous Subcutaneous Insulin Infusion ( CSII)