GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06338553
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide (Rybelsus®) — DRUG
    7 mg single dose of Rybelsus® by mouth once before each MMTT
  • Placebo — DRUG
    placebo capsule or tablet once before each MMTT.

Study Details

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.

Key Dates

Start date
Jun 12, 2024
Status verified
Dec 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
24 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study [ Time Frame: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Daniel J Moore, MD, PhD
[email protected]
(615) 322- 7427
Wendi Welch, CCRP
[email protected]
Daniel J Moore, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Vanderbilt University Medical Center· Nashville, TN

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