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

NCT04120623 | Unknown Phase 4

• 1 other identifier: KY20190926-03
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Continuous Glucose Monitoring System (CGMS); Dapagliflozin; Continuous Subcutaneous Insulin Infusion ( CSII)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• the effects of dapagliflozin combined with CSII on weight

  5 weeks

• the effects of dapagliflozin combined with CSII on blood pressure

  5 weeks

• the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)

  5 weeks

Study Arms (2)

Dapagliflozin combined with CSII

EXPERIMENTAL

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

Drug: Dapagliflozin 10 MG

CSII alone

ACTIVE COMPARATOR

Aspart infused by CSII alone as glucose lowering therapy.

Drug: Insulin Aspart

Interventions

Dapagliflozin 10 MG DRUG

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

Also known as: Dapagliflozin combined with CSII

Dapagliflozin combined with CSII

Insulin Aspart DRUG

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

Also known as: CSII alone

CSII alone

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jianhua Ma

  Nanjing First Hospital, Affiliated to Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Jianhua Ma, Doctor

CONTACT

8625-52887091; majianhua196503@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 9, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: October 9, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share