Systemic Lupus Erythematosus
Conditions
Keywords
metformin, systemic lupus erythematosus
Brief summary
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.
Interventions
DRUGmetformin
500 mg metformin three times daily
DRUGplacebo
500 mg placebo three times daily
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Willingness of the subject to participate in the study, proven by signing the informed consent; * 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; * The course of SLE longer than1 year; and there is a clear record of disease flares in the past 1 year with prednisone more than 20mg/day; * Patients with mild/moderate disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A or no more than one B; * A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/ mycophenolate mofetil/ methotrexate/ ciclosporin/ leflunomide/ thalidomide) for at least 30 days.
Exclusion criteria
* Patients who are unwilling to sign the inform consent; * Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min; * Patients who used cyclophosphamide 6-months before screening; used biological agents 12-months before screening; * Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin; * Patients who diagnosed of diabetes mellitus; * Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| numbers of participants who remained at risk of flares at each visit | one year | the effect of metformin on reducing disease flares |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| changes in prednisone dose from baseline at each visit | one year | the influence of metformin on corticosteroid sparing effect |
| changes in BMI from baseline at each visit | one year | the influence of metformin on BMI |
| number of participants with treatment-related adverse events | one year | the safety of metformin |
Countries
China
Outcome results
None listed