The Effect of Metformin on Reducing Lupus Flares (Met Lupus)
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|ClinicalTrials.gov Identifier: NCT02741960|
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : December 19, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Drug: metformin Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Multicenter, Randomised, Double-blind Placebo Controlled Trial on the Efficacy and Safety of add-on Metformin to Conventional Immunosuppressants in Systemic Lupus Erythematosus|
|Actual Study Start Date :||May 24, 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
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.
500 mg metformin three times daily
Other Name: Metformin Hydrochloride Tablets
Placebo Comparator: 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.
500 mg placebo three times daily
- numbers of participants who remained at risk of flares at each visit [ Time Frame: one year ]the effect of metformin on reducing disease flares
- changes in prednisone dose from baseline at each visit [ Time Frame: one year ]the influence of metformin on corticosteroid sparing effect
- changes in BMI from baseline at each visit [ Time Frame: one year ]the influence of metformin on BMI
- number of participants with treatment-related adverse events [ Time Frame: one year ]the safety of metformin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741960
|Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine|
|Shanghai, Shanghai, China, 200000|
|Principal Investigator:||Shuang Ye, MD||RenJi Hospital|