Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 698 for:    lupus

The Effect of Metformin on Reducing Lupus Flares (Met Lupus)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02741960
Recruitment Status : Active, not recruiting
First Posted : April 18, 2016
Last Update Posted : December 19, 2017
Sponsor:
Information provided by (Responsible Party):
Shuang Ye, RenJi Hospital

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.


Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: metformin Drug: placebo Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: 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.
Drug: metformin
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.
Drug: placebo
500 mg placebo three times daily




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. changes in prednisone dose from baseline at each visit [ Time Frame: one year ]
    the influence of metformin on corticosteroid sparing effect

  2. changes in BMI from baseline at each visit [ Time Frame: one year ]
    the influence of metformin on BMI

  3. number of participants with treatment-related adverse events [ Time Frame: one year ]
    the safety of metformin



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
Layout table for location information
China, Shanghai
Ethics Committee of Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
RenJi Hospital
Investigators
Layout table for investigator information
Principal Investigator: Shuang Ye, MD RenJi Hospital

Publications:
Layout table for additonal information
Responsible Party: Shuang Ye, Executive Director, Dept. Rheumatology, Renji Hospital South Campus, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02741960     History of Changes
Other Study ID Numbers: SHDC12015902
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shuang Ye, RenJi Hospital:
metformin
systemic lupus erythematosus

Additional relevant MeSH terms:
Layout table for MeSH terms
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs