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

NCT ID: NCT04120623

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2020-02-28

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Dapagliflozin combined with CSII

Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.

Group Type: EXPERIMENTAL

Dapagliflozin 10 MG

Intervention Type: DRUG

Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).

CSII alone

Aspart infused by CSII alone as glucose lowering therapy.

Group Type: ACTIVE_COMPARATOR

Insulin Aspart

Intervention Type: DRUG

Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)

Interventions

Dapagliflozin 10 MG

Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).

Intervention Type: DRUG

Insulin Aspart

Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)

Intervention Type: DRUG

Other Intervention Names

Dapagliflozin combined with CSII; CSII alone

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianhua Ma

Role: STUDY_DIRECTOR

Nanjing First Hospital, Affiliated to Nanjing Medical University

Central Contacts

Jianhua Ma, Doctor

Role: CONTACT

majianhua196503@126.com

8625-52887091 ext. +8618951670116

Other Identifiers

KY20190926-03

Identifier Type: -

Identifier Source: org_study_id