A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus
Overview
- Phase
- Phase 4
- Intervention
- metformin
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- RenJi Hospital
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- numbers of participants who remained at risk of flares at each visit
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Shuang Ye
Executive Director, Dept. Rheumatology, Renji Hospital South Campus
RenJi Hospital
Eligibility Criteria
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.
Arms & Interventions
metformin
Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to metformin will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.
Intervention: metformin
placebo
Eligible patients for clinical trial were randomized in a 1:1 ratio to metformin/placebo add-on. Subjects randomized to placebo will receive a target dose of 500 mg three times daily. Investigators were allowed to adjust the dose according to the patients' tolerance.
Intervention: placebo
Outcomes
Primary Outcomes
numbers of participants who remained at risk of flares at each visit
Time Frame: one year
the effect of metformin on reducing disease flares
Secondary Outcomes
- changes in BMI from baseline at each visit(one year)
- changes in prednisone dose from baseline at each visit(one year)
- number of participants with treatment-related adverse events(one year)