This is a multicenter, randomised, double-blind placebo controlled trial on the efficacy and safety of add-on metformin to conventional immunosuppressants in systemic lupus erythematosus (SLE). The purpose of this study is to evaluate: 1) the effect of metformin on reducing disease flares; 2) the influence of metformin on corticosteroid sparing effect; 3) the influence of metformin on body mass index (BMI); 4) the safety of metformin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
180
Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
numbers of participants who remained at risk of flares at each visit
the effect of metformin on reducing disease flares
Time frame: one year
changes in prednisone dose from baseline at each visit
the influence of metformin on corticosteroid sparing effect
Time frame: one year
changes in BMI from baseline at each visit
the influence of metformin on BMI
Time frame: one year
number of participants with treatment-related adverse events
the safety of metformin
Time frame: one year
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