Back to resultsThe Effect of Metformin on Reducing Lupus Flares (Met Lupus)
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
metformin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring metformin, systemic lupus erythematosus
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.
Sites / Locations
- Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
metformin
placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
numbers of participants who remained at risk of flares at each visit
the effect of metformin on reducing disease flares
Secondary Outcome Measures
changes in prednisone dose from baseline at each visit
the influence of metformin on corticosteroid sparing effect
changes in BMI from baseline at each visit
the influence of metformin on BMI
number of participants with treatment-related adverse events
the safety of metformin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02741960
Brief Title
The Effect of Metformin on Reducing Lupus Flares
Acronym
Met Lupus
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 24, 2016 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
December 7, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
metformin, systemic lupus erythematosus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
metformin
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
metformin
Other Intervention Name(s)
Metformin Hydrochloride Tablets
Intervention Description
500 mg metformin three times daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
500 mg placebo three times daily
Primary Outcome Measure Information:
Title
numbers of participants who remained at risk of flares at each visit
Description
the effect of metformin on reducing disease flares
Time Frame
one year
Secondary Outcome Measure Information:
Title
changes in prednisone dose from baseline at each visit
Description
the influence of metformin on corticosteroid sparing effect
Time Frame
one year
Title
changes in BMI from baseline at each visit
Description
the influence of metformin on BMI
Time Frame
one year
Title
number of participants with treatment-related adverse events
Description
the safety of metformin
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shuang Ye, MD
Organizational Affiliation
RenJi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26245802
Citation
Wang H, Li T, Chen S, Gu Y, Ye S. Neutrophil Extracellular Trap Mitochondrial DNA and Its Autoantibody in Systemic Lupus Erythematosus and a Proof-of-Concept Trial of Metformin. Arthritis Rheumatol. 2015 Dec;67(12):3190-200. doi: 10.1002/art.39296.
Results Reference
background
PubMed Identifier
33093216
Citation
Sun F, Geng S, Wang H, Wang H, Liu Z, Wang X, Li T, Wan W, Lu L, Teng X, Morel L, Ye S. Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials. Lupus Sci Med. 2020 Oct;7(1):e000429. doi: 10.1136/lupus-2020-000429.
Results Reference
derived
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The Effect of Metformin on Reducing Lupus Flares
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