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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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5 March 2018 |
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Main ID: |
ChiCTR1800015030 |
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Date of registration:
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2018-03-01 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus Erythematosus
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Scientific title:
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The Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLE |
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Date of first enrolment:
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2018-03-01 |
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Target sample size:
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Case series:35; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=25617 |
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Study type:
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Observational study |
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Study design:
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Before-After control
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Phase:
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IV (Phase IV study)
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Countries of recruitment
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China
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Contacts
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Name:
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Shuang Ye
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Address:
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2000 Jiangyue Road Road, Shanghai, China
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Telephone:
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+86 13817615871 |
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Email:
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ye_shuang2000@163.com |
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Affiliation:
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Dept. Rheumatology, Renji Hospital South Campus |
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Name:
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Huijing Wang
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Address:
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2000 Jiangyue Road, Shanghai, China
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Telephone:
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+86 18267851823 |
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Email:
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whj30813@163.com |
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Affiliation:
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Dept. Rheumatology, Renji Hospital South Campus |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1) Willingness of the subject to participate in the study, proven by signing the informed consent;
2) Age at least 18 years old;
3) Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
4) Patients who diagnosed of diabetes mellitus; or glycated albumin(GA)>16% or glycosylated hemoglobin(Hb1c)>6%;or blood glucose > 7.8mmol/L at any time in oral glucose tolerance test(OGTT).
Exclusion criteria: 1) Patients who are unwilling to sign the inform consent;
2) Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 45ml/min;
3) Patients who are suffering from infections;
4) Previous exposure of other clinical trails within 3 months before screening;
5) Pregnancy or lactation;
6) patients with mental diseases.
Age minimum:
18
Age maximum:
70
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Intervention(s)
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Case series:add-on or replace dapagliflozin;
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Primary Outcome(s)
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WBC in urine;blood glucose;glycated albumin or glycosylated hemoglobin;C3/C4;unire protein;blood fat;dsDNA;
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Secondary Outcome(s)
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BMI;ESR;CRP;ALT;Cr;blood pressure;
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Source(s) of Monetary Support
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The Department's own expense
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Ethics review
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Status: Approved
Approval date:
Contact:
Qi Lu
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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