Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab

Registration

Registration

NCT06338553

Acronym

GLP-TEP

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

EARLY_PHASE1

Masking

QUADRUPLE

Status

RECRUITING

Enrollment

24

Start

2024-06-12

Primary completion

2027-03

Lead sponsor

Vanderbilt University Medical Center

Conditions

Type 1 Diabetes

Interventions

DRUG:Semaglutide (Rybelsus®); DRUG:Placebo

Results posted

FALSE

Individual participant data sharing

YES

Secondary identifiers

NIH:R01DK139322

Registered primary outcomes

• 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]