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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin combined with CSII | Experimental | Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy. |
|
| CSII alone | Active Comparator | Aspart infused by CSII alone as glucose lowering therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin 10 MG | Drug | Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII). |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Ma, Doctor | Contact | 8625-52887091 | +8618951670116 | majianhua196503@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianhua Ma | Nanjing First Hospital, Affiliated to Nanjing Medical University | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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|
| Insulin Aspart | Drug | Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII) |
|
|
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 |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |