This is a double blinded, randomized, placebo controlled clinical trial of 40 participants with pulmonary sarcoidosis. Primary Objective: To assess the steroid-sparing efficacy and safety of oral metformin therapy in participants with confirmed progressive pulmonary sarcoidosis for participants with steroid dependent disease.
The purpose of this study is to assess the efficacy of Metformin therapy in terms of steroid-sparing efficacy for sarcoidosis patients with steroid-dependent disease. Given that the morbidity and mortality has proven to be significant in patients with sarcoidosis, we believe there is unprecedented opportunity for improved clinical outcomes if the right interventional agent can be identified. In choosing steroid-sparing effect as the primary outcome, we will be able to detect changes in clinical outcomes that are important to patients and to the scientific community. We anticipate that these improvements will reduce or resolve the necessity of immunosuppressant therapy in these participants. At least 40 participants will be randomized in equal proportion to metformin or placebo. Twenty completed participants per arm provide 80% power to reject (one-sided type I error of 5%) the null hypothesis that mean daily steroid use in the placebo treated group is less than in the metformin treated group using analysis of covariance adjusting for baseline average steroid use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
To assess the steroid-sparing efficacy and safety of oral metformin therapy in patients with progressive pulmonary sarcoidosis.
Mean daily oral corticosteroid dose post protocol-driven steroid taper at 24-weeks after randomization.
Time frame: 24 weeks
To compare cumulative total steroid use between those randomized to metformin or placebo
• Average dose and cumulative total steroid use in the 24-week study horizon.
Time frame: 24 weeks
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