Review by Joseph Ross – 05/14/2018 – 4:18pm

Data Request Number: No Data Request Assigned Is the scientific purpose of the research proposal clearly described?: Yes Will request create or materially enhance generalizable scientific and/or medical knowledge to inform science and public health?: Yes Can the proposed research be reasonably addressed using the requested data?: Yes, or it’s highly likely Please use this space to provide any comments, feedback or concerns (optional):

This proposal is a useful investigation of the pharmacokinetics of bedaquiline among patients with type 2 diabetes mellitus using either metformin or a sulfonylurea. My only concern with the proposal is whether pharmacokinetic data are available for the 2 trials requested. If available, this research will provide useful information for patients using bedaquiline concomitantly with either metformin or a sulfonylurea.

Recommendation for this data request: Approve