Status:

UNKNOWN

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

Lead Sponsor:

Nanjing First Hospital, Nanjing Medical University

Conditions:

Type 2 Diabetes Mellitus

Eligibility:

All Genders

18-80 years

Phase:

PHASE4

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...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

October 1 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 28 2020

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT04120623

Start Date

October 1 2019

End Date

February 28 2020

Last Update

October 9 2019

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