Type 1 DiabetesEarly Phase 1GLP-TEPNCT06338553
GLP-1Ra Impact on Metabolic Outcomes in Stage 2 T1DM While Receiving Teplizumab
A Early Phase 1 study testing Semaglutide (Rybelsus®) in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Semaglutide (Rybelsus®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Comorbidities:
- SBP > 140 mmHg and DBP > 100 mmHg
- eGFR by MDRD equation of < 60 mL/min/1.73m2
- AST or ALT > 2.5 times ULN
- Family history of medullary thyroid carcinoma
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
Show all 21Show fewer
- Medications: Any diabetes medication, any antioxidant vitamin supplement (<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with > 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- Other: pregnancy, peri- or post-menopausal women, active smoker
- Aim 4: Early Stage 3 T1DM with GLP-1Ra Monotherapy Inclusion Criteria
- Age: 12-50 years
- BMI: 18-31 kg/m2 (adults) or 5-95th %ile (pediatric)
- Early stage 3 T1DM with either
- HbA1c 6.5% to 8.0% at diagnosis OR
- HbA1c 5.7% to 6.4% with oral glucose test meeting ADA criteria for stage 3 T1DM within the past three months prior to or during screening visit
- Time of stage 3 diagnosis: within eight weeks of first study visit
- DKA history: history of diabetic ketoacidosis requiring hospital admission
- Comorbidities:
- Family history of medullary thyroid carcinoma
- Diagnosis of pancreatitis or gastroparesis within the past 3 years
- Medications: Any diabetes medication, any antioxidant vitamin supplement (<2 weeks before a study), any systemic glucocorticoid, antipsychotic, atenolol, metoprolol, propranolol, niacin, any thiazide diuretic, any OCP with > 35 mcg ethinyl estradiol, growth hormone, any immunosuppressant, antihypertensive, any antihyperlipidemic
- Other: pregnancy, peri- or post-menopausal women, active smoker
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Wendi Welch, CCRP contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Daniel J Moore, MD, PhD, (615) 322- 7427, metabolism@vumc.org
Wendi Welch, CCRP, metabolism@vumc.org
About this study
Official title: Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab
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.
Read the detailed description
The long-term goal is to determine whether repurposing GLP-1Ra for stage 2 in combination with immunotherapy can modify the disease course, reducing the need for exogenous insulin therapy and leading to improved cardiometabolic outcomes and quality of life. For early stage 3 T1DM, we aim to determine whether GLP-1Ra can offer similar protective effects in preserving β-cell function and stabilizing glycemic control.
The immediate objective is to investigate the impact of GLP-1Ra's insulinotropic and glucagonostatic effects on dysmetabolism in stage 2 and early stage 3 T1DM. The study hypothesizes that these effects will each delay the need for exogenous insulin by improving three key aspects of dysmetabolism: 1) postprandial glycemia, 2) disposition index (i.e., the ability of the islet cells to compensate for a given insulin sensitivity), and 3) endothelial function. The rationale for this hypothesis is based on two observations: first, GLP-1Ra combined with immunomodulatory therapy sustains endogenous secretion in response to a mixed meal tolerance test (MMTT) during the first year of stage 3; and second, GLP-1Ras mitigate postprandial hyperglucagonemia in longer-duration T1DM. To test the hypothesis, studies will be conduct in individuals with stage 2 T1DM treated with teplizumab using a crossover design structured around the following specific aims:
Aim 1: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study. The study team will measure postprandial glycemia during an MMTT before teplizumab treatment. After teplizumab the study team will compare the effects of placebo versus semaglutide (a GLP-1Ra).
Aim 2: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study. The study team will use the oral glucose minimal model to measure DI during an MMTT before and after teplizumab treatment, comparing the effects of placebo versus semaglutide. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be quantified by measuring the proinsulin-to-C-peptide ratio during the MMTT.
Aim 3: Determine the impact of GLP-1Ra on endothelial function in a pilot study. The study team will use B-mode ultrasound to measure flow mediated vasodilation (FMD), a bioassay of endothelial function, during each MMTT. Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance, the study aims to illuminate how GLP-1Ra may mitigate early vascular disease progression.
And in a pilot study of early stage 3 T1DM, 4) GLP-1 Receptor Agonists. Aim 4: Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM.
Despite the promise of TZIELD®, the medication is not currently approved for patients with stage 3 T1DM. Thus, individuals who progress into stage 3 T1DM continue to face significant challenges, including loss of β-cell function and the need for exogenous insulin. As patients move into stage 3, there is an opportunity for metabolic interventions that may preserve residual insulin production and mitigate the long-term impact of hyperglycemia. Accordingly, we will conduct a randomized, double-blind, placebo-controlled crossover study involving patients with early stage 3 T1DM. Each participant will undergo four mixed meal tolerance tests (MMTTs): two at baseline shortly after diagnosis and two after a six-month interval. During each MMTT, participants will receive either a single dose of GLP-1Ra (oral semaglutide) or placebo in a randomized order. This design allows us to assess the independent effects of GLP-1Ra on the disposition index (DI) by comparing the results between the GLP-1Ra and placebo conditions at both time points. By evaluating changes in DI and other metabolic parameters over time, we aim to determine how GLP-1Ra monotherapy influences β-cell function and insulin sensitivity in early stage 3 T1DM.
- Conditions
- Type 1 Diabetes
- Being tested
- Semaglutide (Rybelsus®), Placebo
- Keywords
- Type 1 Diabetes, Stage 2 Type 1 Diabetes, Early Stage Type 1 Diabetes, GLP1-Ra, Rybelsus, mixed meal tolerance test (MMTT), Stage 3 Type 1 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide (Rybelsus®)Drug
7 mg single dose of Rybelsus® by mouth once before each MMTT
PlaceboDrug
placebo capsule or tablet once before each MMTT.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving placebo, Stage 2 T1DM participants | Placebo comparator | 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. Receives: Drug: Placebo |
| Participants receiving a semaglutide (Rybelsus®), Stage 2 T1DM participants | Experimental | Participants receive 7mg of semaglutide (Rybelsus®) orally once before one of the post-TZIELD® MMTTs. Rybelsus is only given one time. Receives: Drug: Semaglutide (Rybelsus®) |
| Placebo Comparator: Participants receiving placebo, Stage 3 T1DM participants | Placebo comparator | Participants receive a placebo orally once before each MMTT. Receives: Drug: Placebo |
| Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 3 T1DM participants | Experimental | Participants receive 7mg of semaglutide (Rybelsus®) orally once before each MMTT. Receives: Drug: Semaglutide (Rybelsus®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study
Researchers will measure postprandial glycemia during an MMTT before TZIELD® treatment. After TZIELD®, the effects of placebo versus semaglutide (Rybelsus®),a GLP-1Ra, will be compared.
Measured: 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
Researchers will use the oral glucose minimal model to measure DI during an MMTT before and after TZIELD® treatment, comparing the effects of placebo versus Rybelsus®. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be determined by measuring the proinsulin-to-C-peptide ratio during the MMTT.
Measured: 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
B-mode ultrasound will be used to measure flow-mediated vasodilation (FMD), a bioassay of endothelial function, during each MMTT. Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance, researchers aim to illuminate how GLP-1Ra may mitigate early vascular disease progression.
Measured: 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.
Researchers will assess the independent effects of GLP-1Ra on the disposition index (DI) by comparing the results between the GLP-1Ra and placebo conditions during four mixed meal tolerance tests (MMTTs): two at baseline shortly after diagnosis and two after a six-month interval.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start12 Jun 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- In this study, participants with stage 2 T1DM undergoing Teplizumab treatment will be randomly assigned to receive single doses of either a GLP-1Ra (oral semaglutide, Rybelsus®) or a placebo, and three separate Mixed Meal Tolerance Test (MMTT) tests, 3-5 months apart, will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. Participants with early stage 3 T1DM will undergo four MMTT studies: two at baseline shortly after diagnosis and two after a six-month interval. During each pair of studies, participants will receive a single dose of GLP-1Ra (oral semaglutide, Rybelsus®) in one study and placebo in the other, with the order randomized to minimize potential sequencing effects. This approach allows us to assess the effects of GLP-1Ra on metabolic parameters and β-cell function at two critical time points in disease progression, shortly after diagnosis and after a six-month interval.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Moore, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338553
- Sponsor's protocol ID
- 231620
- Other IDs
- R01DK139322
- Acronym
- GLP-TEP
- Status last verified
- Dec 2025
- First submitted
- 7 Mar 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in type 1 diabetes. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Stage 2 T1DM Management: Assessing the Impact of GLP-1Ra on Metabolic Outcomes in Patients Receiving Teplizumab
- ClinicalTrials.gov ID
- NCT06338553
- Acronym / sponsor ID
- GLP-TEP / 231620
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Stage 2 Type 1 Diabetes, Early Stage Type 1 Diabetes, GLP1-Ra, Rybelsus, mixed meal tolerance test (MMTT), Stage 3 Type 1 Diabetes
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The long-term goal is to determine whether repurposing GLP-1Ra for stage 2 in combination with immunotherapy can modify the disease course, reducing the need for exogenous insulin therapy and leading to improved cardiometabolic outcomes and quality of life. For early stage 3 T1DM, we aim to determine whether GLP-1Ra can offer similar protective effects in preserving β-cell function and stabilizing glycemic control.
The immediate objective is to investigate the impact of GLP-1Ra's insulinotropic and glucagonostatic effects on dysmetabolism in stage 2 and early stage 3 T1DM. The study hypothesizes that these effects will each delay the need for exogenous insulin by improving three key aspects of dysmetabolism: 1) postprandial glycemia, 2) disposition index (i.e., the ability of the islet cells to compensate for a given insulin sensitivity), and 3) endothelial function. The rationale for this hypothesis is based on two observations: first, GLP-1Ra combined with immunomodulatory therapy sustains endogenous secretion in response to a mixed meal tolerance test (MMTT) during the first year of stage 3; and second, GLP-1Ras mitigate postprandial hyperglucagonemia in longer-duration T1DM. To test the hypothesis, studies will be conduct in individuals with stage 2 T1DM treated with teplizumab using a crossover design structured around the following specific aims:
Aim 1: Investigate the impact of GLP-1Ra on postprandial glycemia in a pilot study. The study team will measure postprandial glycemia during an MMTT before teplizumab treatment. After teplizumab the study team will compare the effects of placebo versus semaglutide (a GLP-1Ra).
Aim 2: Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study. The study team will use the oral glucose minimal model to measure DI during an MMTT before and after teplizumab treatment, comparing the effects of placebo versus semaglutide. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be quantified by measuring the proinsulin-to-C-peptide ratio during the MMTT.
Aim 3: Determine the impact of GLP-1Ra on endothelial function in a pilot study. The study team will use B-mode ultrasound to measure flow mediated vasodilation (FMD), a bioassay of endothelial function, during each MMTT. Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance, the study aims to illuminate how GLP-1Ra may mitigate early vascular disease progression.
And in a pilot study of early stage 3 T1DM, 4) GLP-1 Receptor Agonists. Aim 4: Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM.
Despite the promise of TZIELD®, the medication is not currently approved for patients with stage 3 T1DM. Thus, individuals who progress into stage 3 T1DM continue to face significant challenges, including loss of β-cell function and the need for exogenous insulin. As patients move into stage 3, there is an opportunity for metabolic interventions that may preserve residual insulin production and mitigate the long-term impact of hyperglycemia. Accordingly, we will conduct a randomized, double-blind, placebo-controlled crossover study involving patients with early stage 3 T1DM. Each participant will undergo four mixed meal tolerance tests (MMTTs): two at baseline shortly after diagnosis and two after a six-month interval. During each MMTT, participants will receive either a single dose of GLP-1Ra (oral semaglutide) or placebo in a randomized order. This design allows us to assess the independent effects of GLP-1Ra on the disposition index (DI) by comparing the results between the GLP-1Ra and placebo conditions at both time points. By evaluating changes in DI and other metabolic parameters over time, we aim to determine how GLP-1Ra monotherapy influences β-cell function and insulin sensitivity in early stage 3 T1DM.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- In this study, participants with stage 2 T1DM undergoing Teplizumab treatment will be randomly assigned to receive single doses of either a GLP-1Ra (oral semaglutide, Rybelsus®) or a placebo, and three separate Mixed Meal Tolerance Test (MMTT) tests, 3-5 months apart, will be conducted to assess the effects on blood sugar levels, insulin function, and vascular health. Participants with early stage 3 T1DM will undergo four MMTT studies: two at baseline shortly after diagnosis and two after a six-month interval. During each pair of studies, participants will receive a single dose of GLP-1Ra (oral semaglutide, Rybelsus®) in one study and placebo in the other, with the order randomized to minimize potential sequencing effects. This approach allows us to assess the effects of GLP-1Ra on metabolic parameters and β-cell function at two critical time points in disease progression, shortly after diagnosis and after a six-month interval.
| Arm | Type | Receives |
|---|---|---|
| Participants receiving placebo, Stage 2 T1DM participants | Placebo comparator | Drug: PlaceboParticipants receive a placebo orally once before the pre-TZIELD® MMTT. Participants also receive a placebo orally once before one of the post-TZIELD® MMTTs. |
| Participants receiving a semaglutide (Rybelsus®), Stage 2 T1DM participants | Experimental | Drug: Semaglutide (Rybelsus®)Participants receive 7mg of semaglutide (Rybelsus®) orally once before one of the post-TZIELD® MMTTs. Rybelsus is only given one time. |
| Placebo Comparator: Participants receiving placebo, Stage 3 T1DM participants | Placebo comparator | Drug: PlaceboParticipants receive a placebo orally once before each MMTT. |
| Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 3 T1DM participants | Experimental | Drug: Semaglutide (Rybelsus®)Participants receive 7mg of semaglutide (Rybelsus®) orally once before each MMTT. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- Comorbidities:
- SBP > 140 mmHg and DBP > 100 mmHg
- eGFR by MDRD equation of < 60 mL/min/1.73m2
- AST or ALT > 2.5 times ULN
- Family history of medullary thyroid carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide (Rybelsus®)7 mg single dose of Rybelsus® by mouth once before each MMTT | Drug | Experimental: Participants receiving a semaglutide (Rybelsus®), Stage 3 T1DM participants, Participants receiving a semaglutide (Rybelsus®), Stage 2 T1DM participants |
| Placeboplacebo capsule or tablet once before each MMTT. | Drug | Participants receiving placebo, Stage 2 T1DM participants, Placebo Comparator: Participants receiving placebo, Stage 3 T1DM participants |
Primary outcome
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
Researchers will measure postprandial glycemia during an MMTT before TZIELD® treatment. After TZIELD®, the effects of placebo versus semaglutide (Rybelsus®),a GLP-1Ra, will be compared.
Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study
Time frame: 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.
Researchers will use the oral glucose minimal model to measure DI during an MMTT before and after TZIELD® treatment, comparing the effects of placebo versus Rybelsus®. As an exploratory outcome, β-cell endoplasmic reticulum dysfunction will be determined by measuring the proinsulin-to-C-peptide ratio during the MMTT.
Determine the impact of GLP-1Ra on endothelial function in a pilot study
Time frame: During the last 30 minutes of each MMTT, between the 210 and 240 timepoints
B-mode ultrasound will be used to measure flow-mediated vasodilation (FMD), a bioassay of endothelial function, during each MMTT. Because endothelial cells are often among the first affected by hyperglycemia and insulin resistance, researchers aim to illuminate how GLP-1Ra may mitigate early vascular disease progression.
Determine how much GLP-1Ra monotherapy therapy changes the disposition index (DI) in a pilot study of early stage 3 T1DM.
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
Researchers will assess the independent effects of GLP-1Ra on the disposition index (DI) by comparing the results between the GLP-1Ra and placebo conditions during four mixed meal tolerance tests (MMTTs): two at baseline shortly after diagnosis and two after a six-month interval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in type 1 diabetes. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wendi Welch, CCRP contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Semaglutide (Rybelsus®) in people with Type 1 Diabetes, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel J Moore, MD, PhD ((615) 322- 7427, metabolism@vumc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.