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

Phase 4UnknownNCT04120623

Nanjing First Hospital, Nanjing Medical University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Type 2 Diabetes Mellitus

Interventions

Dapagliflozin 10 MGDRUG

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

Insulin AspartDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Time frame: 5 weeks

Secondary Outcomes

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

Time frame: 5 weeks

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

Time frame: 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)

Time frame: 5 weeks

Central Contacts

Jianhua Ma, Doctor

CONTACT

8625-52887091 majianhua196503@126.com

Data from ClinicalTrials.gov

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