DelfaGLP-1 Atlas

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GLP-TEP

RecruitingPhase EARLY_1

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

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

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

24

estimated

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoints

•Postprandial glucose•Study the impact of GLP-1Ra on the disposition index (DI) in a pilot study•Determine the impact of GLP-1Ra on endothelial function in a pilot study

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06338553
Org study ID231620
Secondary IDR01DK139322

Timeline

Milestones

Study first posted2024-03-29actual
Study start2024-06-12actual
Last update posted2025-12-18actual
Primary completion2027-03estimated (month precision)
Study completion2027-03estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age12 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Aims 1-3: Stage 2 T1DM with TZIELD® and GLP-1Ra

Inclusion Criteria:

•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)

Exclusion criteria

•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
•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

Exclusion Criteria

•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

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
3
Other (unclassified)
1

Glycemic / diabetes

3 endpoints
Primary/protocol endpoint

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

Postprandial glucose

descriptive

Primary/protocol endpoint

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.

change from baseline, improvement

Primary/protocol endpoint/low confidence

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

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.