Type 2 Diabetes Mellitus
Conditions
Keywords
Continuous Glucose Monitoring System (CGMS), Dapagliflozin, Continuous Subcutaneous Insulin Infusion ( CSII)
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.
Interventions
DRUGDapagliflozin 10 MG
Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
DRUGInsulin Aspart
Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)
Sponsors
Nanjing First Hospital, Nanjing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the effect of dapagliflozin combined with CSII on glucose profile | 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
| Measure | Time frame | Description |
|---|---|---|
| the effects of dapagliflozin combined with CSII on weight | 5 weeks | 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 | 5 weeks | 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) | 5 weeks | 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) |
Contacts
Primary ContactJianhua Ma, Doctor
Outcome results
None listed