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

Phase 4

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Dapagliflozin 10 MG; Drug: Insulin Aspart

• Registration Number: NCT04120623
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Status Verified: 2019-09
• Study First Submitted: 2019-09-29
• Study Start: 2019-10-01
• Study First Submitted QC: 2019-10-07
• Last Update Submitted: 2019-10-07
• Study First Posted: 2019-10-09
• Last Update Posted: 2019-10-09
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dapagliflozin combined with CSII	Dapagliflozin 10 MG	Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.
CSII alone	Insulin Aspart	Aspart infused by CSII alone as glucose lowering therapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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)