Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05910554
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2023-06-06
Brief Title:
Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Investigation of the Efficacy of Metformin Therapy on Pulmonary Sarcoidosis Phase II Randomized Double-blind Placebo-controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MetforminTOP
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None