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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

The goal of this study is to determine how a drug class called glucagon-like peptide-1 receptor agonists (GLP-1Ra) affects people during an early stage of Type 1 Diabetes undergoing clinical teplizumab treatment. This study involves giving participants a liquid meal under different conditions and observing how their bodies respond, focusing on blood sugar levels, insulin effectiveness, and blood vessel function. The meal tests are followed by two post-treatment tests, one with the GLP-1Ra drug and the other with a placebo. Each test involves blood draws before and during the meal test, GLP-1Ra or placebo administration, and an ultrasound to measure blood vessel function. The goal is to see if GLP-1Ra can help manage blood sugar levels and improve cardiovascular health in this population.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 50
Healthy Volunteers: f
View:

• Age: 12-50 years

• BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)

• Stage 2 T1DM (i.e., ≥ 2 islet auto-antibodies and:

• fasting glucose ≥ 100 mg/dL and \< 126 mg/dL OR

• 2-hr OGTT /MMTT ≥ 140 mg/dL and \< 200 mg/dL OR

• During an OGTT having a glucose of \> 199 mg/dL at 30, 60, or 90 minutes)

Locations
United States
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Contact Information
Primary
Justin M Gregroy, MD, MSCI
metabolism@vumc.org
(615) 322- 7427
Backup
Wendi Welch, CCRP
metabolism@vumc.org
Time Frame
Start Date: 2024-06-12
Estimated Completion Date: 2027-03
Participants
Target number of participants: 24
Treatments
Placebo_comparator: Participants receiving placebo, Stage 2 T1DM participants
Participants receive a placebo orally once before the pre-TZIELD® MMTT. Participants also receive a placebo orally once before one of the post-TZIELD® MMTTs.
Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 2 T1DM participants
Participants receive 7mg of semaglutide (Rybelsus®) orally once before one of the post-TZIELD® MMTTs. Rybelsus is only given one time.
Placebo_comparator: Placebo Comparator: Participants receiving placebo, Stage 3 T1DM participants
Participants receive a placebo orally once before each MMTT.
Experimental: Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 3 T1DM participants
Participants receive 7mg of semaglutide (Rybelsus®) orally once before each MMTT.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Vanderbilt University Medical Center

This content was sourced from clinicaltrials.gov