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A Clinical Trial on Safety and effect of Dapagliflozin to Control Blood Glucose Levels in Systemic Lupus Erythematosus

The Safety of SGLT2-i Dapagliflozin on Treating Blood Glucose Levels in SLE

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800015030
Enrollment
Unknown
Registered
2018-03-01
Start date
2018-03-01
Completion date
Unknown
Last updated
2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Interventions

Case series:add-on or replace dapagliflozin

Sponsors

Dept. Rheumatology, Renji Hospital South Campus
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
WBC in urine;blood glucose;glycated albumin or glycosylated hemoglobin;C3/C4;unire protein;blood fat;dsDNA;

Secondary

MeasureTime frame
BMI;ESR;CRP;ALT;Cr;blood pressure;

Countries

China

Contacts

Public ContactShuang Ye

Dept. Rheumatology, Renji Hospital South Campus

ye_shuang2000@163.com+86 13817615871

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026