- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04120623
Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus
October 7, 2019 updated by: Nanjing First Hospital, Nanjing Medical University
Therapeutic Effect of Dapagliflozin Combined With CSII on Newly Diagnosed Type 2 Diabetes Mellitus With Continuous Glucose Monitoring System
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jianhua Ma, Doctor
- Phone Number: +8618951670116 8625-52887091
- Email: majianhua196503@126.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Dapagliflozin combined with CSII
Dapagliflozin 10MG combined with Aspart infused by CSII as glucose lowering therapy.
|
Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
Other Names:
|
ACTIVE_COMPARATOR: CSII alone
Aspart infused by CSII alone as glucose lowering therapy.
|
Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the effect of dapagliflozin combined with CSII on glucose profile
Time Frame: 5 weeks
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the effects of dapagliflozin combined with CSII on weight
Time Frame: 5 weeks
|
To compare the effect of dapagliflozin combined with CSII and CSII alone on weight in kilogram
|
5 weeks
|
the effects of dapagliflozin combined with CSII on blood pressure
Time Frame: 5 weeks
|
To compare the effect of dapagliflozin combined with CSII and CSII alone on blood pressure in mmHg
|
5 weeks
|
the effects of dapagliflozin combined with CSII on lipid metabolism(total cholesterol in mmol/l, total glyceride in mmol/l)
Time Frame: 5 weeks
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jianhua Ma, Nanjing First Hospital, Affiliated to Nanjing Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
October 1, 2019
Primary Completion (ANTICIPATED)
December 31, 2019
Study Completion (ANTICIPATED)
February 28, 2020
Study Registration Dates
First Submitted
September 29, 2019
First Submitted That Met QC Criteria
October 7, 2019
First Posted (ACTUAL)
October 9, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 9, 2019
Last Update Submitted That Met QC Criteria
October 7, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20190926-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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