DelfaGLP-1 Atlas

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SHIELD-T1D

Not yet recruitingPhase 2

SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.

Recombinant Zoster Vaccine (Shingrix) and GLP-1 Receptor Agonist for the Preservation of Beta-Cell Function in Adults With Recent-Onset Type 1 Diabetes: A Randomized, Double-Blind, Placebo-Controlled Phase II Trial.

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

240

estimated

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•2-hour stimulated C-peptide Area Under the Curve (AUC) during a Mixed Meal

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 IDNCT07614412
Org study IDshingrix-Glp1-type1 diabetes

Timeline

Milestones

Study first posted2026-05-29actual
Last update posted2026-05-29actual
Study start2027-01-01estimated
Primary completion2028-01-31estimated
Study completion2028-12-31estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Diagnosis of Type 1 Diabetes (T1D) according to American Diabetes Association (ADA) criteria.

2. Age 18 to 50 years (inclusive) at the time of screening.

3. Randomization within 100 days of the first insulin injection.

4. Confirmed residual beta-cell function, defined as a peak stimulated C-peptide level ≥0.2 nmol/L during a Mixed Meal Tolerance Test (MMTT) performed at screening.

5. Presence of at least one T1D-related autoantibody (GADA, IA-2A, ZnT8A, or ICA).

6. Willingness to comply with intensive insulin therapy and glucose monitoring.

7. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception.

Exclusion criteria

1. History of diabetic ketoacidosis (DKA) within 4 weeks of screening.

2. Prior use of any immunotherapy or investigational agents for T1D.

3. Current or prior use of GLP-1 receptor agonists, DPP-4 inhibitors, or SGLT2 inhibitors.

4. History of pancreatitis or medullary thyroid carcinoma.

5. Active or chronic infection (e.g., HIV, Hepatitis B or C, Tuberculosis).

6. Pregnancy or breastfeeding.

7. Significant renal, hepatic, or cardiovascular disease.

8. History of severe allergic reaction to any component of the Recombinant Zoster Vaccine (Shingrix) or semaglutide.

9. Current use of systemic corticosteroids or other immunosuppressive medications.

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

Change in 2-hour stimulated C-peptide Area Under the Curve (AUC) during a Mixed Meal Tolerance Test (MMTT)

Time frame:Baseline and 12 months

change from baseline, improvement

Secondary/protocol endpoint

Glycated Hemoglobin (HbA1c) levels

Time frame:Baseline, 12 months, and 24 months

descriptive

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.