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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04120623
• Other study ID #: KY20190926-03
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: September 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Jianhua Ma, Doctor
• Phone: 8625-52887091
• Email: majianhua196503[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Dapagliflozin 10 MG
Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
• Insulin Aspart
Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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