GLP-1RA added around teplizumab in stage-2 T1D: review notes

Outcome: No additional discrepancy identified in the reviewed summary/design/endpoint and eligibility fields. Existing sponsor or historical claims are not all independently certified by this protocol comparison.

Registry: NCT06338553. Endpoint reviewed: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study (During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes); Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study (Based on the glucose and insulin readings obtained at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 min and calculated approximately 1 month following completion of the MMTT once insulin levels in plasma are resulted.); Determine the impact of GLP-1Ra on endothelial function in a pilot study (During the last 30 minutes of each MMTT, between the 210 and 240 timepoints); Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM. (During the MMTT in which the participant is randomly selected to receive semaglutide (Rybelsus®), glucose level will be checked at timepoints -30, -15, 0, 10, 20, 30, 60, 90, 120, 150, 180, and 240 minutes). Eligibility reviewed: Age 12 Years to 50 Years; diagnosis/stage, prior therapy and key biomarker criteria compared with site summary. Full exclusions remain in the registry. Literature access limit: No usable primary abstract was independently recovered for this record in this pass. Current registry protocol was the main source; detailed sponsor or conference data remain dependent on the cited source and were not fully reverified.