The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-TRC-12002419
• Date of registration: 2012-08-01
• Prospective Registration: Yes
• Primary sponsor: Renji Hospital, Shanghai JiaoTong University School of Medicine
• Public title: The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients
• Scientific title: The clinical research of metformin in achievienging the reduction in Flare of Mild/Moderate Active Lupus Patients
• Date of first enrolment: 2012-09-01
• Target sample size: 1:60;2:60;3:60;
• Recruitment status: Completed
• URL: http://www.chictr.org.cn/showproj.aspx?proj=7131
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: Other

Countries of recruitment

China

Contacts

• Name: Wang Haiting
• Affiliation: Shanghai JiaoTong University School of Medicine

• Name: Ye Shuang

Key inclusion & exclusion criteria

Inclusion criteria: 1. Willingness of the subject to participate in the study, proven by signing the informed consent;
2. Men or woman, of at least 18 years of age;
3. SLE, as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of Systemic Lupus Erytematous, either sequeantiallysequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
4. Patients with active disease (score>=6 at screening on SELENA- SLEDAI); no more than one BILAG B score in all organ system;
5. Patients with quiescent disease - mild or moderate form (BILAG C score or better in all organ system);
6. Patients with a stable treatment regimen, with fixed doses of prednisone (0-40mg30mg/day), or common immunosupresiveimmunosuppressive agents (Hyidroxyicloqiune, /Cloroquine, Azathiporine,MMF, CyA, Leflunomide, Methotrexate), for at least 30 days before the first study dose (Metformin or placebo).
Exclusion criteria: 1. Patients with non-quiescent form of SLE (BILAG A or more than two B in at least one organ system);
2. Patients with current symptoms of severe, progressive, or uncontrolled SLE/non-SLE related -related CNCS, renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, involvement;
3. Patients with liver, cardiac or renal failure (SLE/non-SLE related);
4. Patients with current symptoms of severe, progresive, or uncontroled non-SLE related LFT> 1.5 times upper normal limits; serum creatinine > upper normal limitsrenal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine, or cerebral disease;
5. Patients that used 30 days before screening Cyicoolophfosfphomide, MMF, Cyclosporine, Tacrolimus or 6-months0 days before screening; ever used biological agents before (concomitant use of biologics or cycolphosphomide are also not allowed);
6. Previous exposure of Metformin within 30 days before screening; or previous history of intolerant to metformin.

Age minimum: 18
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

1:Background treatment( - hydroxychloroquine );2:Background treatment( + hydroxychloroquine );3:Background treatment + hydroxychloroquine + Metformin;

Primary Outcome(s)

Systemic Lupus Erythematosus Disease Activity Index;

Secondary Outcome(s)

dose of Corticosteroids;carotid intima-media thickness;

Source(s) of Monetary Support

Shanghai Zhongxi Pharmaceutical (Group) Co., Ltd.