NCT05910554

Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis

Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis Phase II Randomized, Double-blind, Placebo-controlled Trial

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Sarcoidosis, Pulmonary

Interventions

Type	Name	Description
DRUG	Metformin	Patients randomized to metformin will be assigned the active arm.
DRUG	Cellulose	Patients randomized to cellulose will be assigned the placebo arm.

Timeline

• Start date: 2025-12-10
• Primary completion: 2027-06-01
• Completion: 2027-09-01
• First posted: 2023-06-18
• Last updated: 2025-02-11

Regulatory

• FDA-regulated drug study