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CompletedPhase EARLY_1

Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D

Targeting Beta Cell Dysfunction in Longstanding T1D

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

Enrollment

16

actual

Study population

Type 1 diabetes

Key I/E criterion

HbA1c ≤8.5%

Primary endpoint

Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL

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 IDNCT03632759
Org study IDIRB18-044

Timeline

Milestones

Study first posted2018-08-15actual
Study start2018-08-15actual
Primary completion2021-11-09actual
Study completion2021-11-09actual
Last update posted2022-01-24actual

Assets

Investigational agents

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. ≥ 3 years from Type 1 diabetes diagnosis

2. Males and females 18-50 years of age, inclusive

3. Peak MMTT stimulated C-peptide <0.017 pmol/mL

4. Proinsulin levels ≥ 2 pM (either fasting or stimulated)

5. Females of child-bearing potential must be willing to use effective birth control for 12 weeks

6. Willing and able to give informed consent for participation

7. HbA1c ≤ 8.5%

Exclusion criteria

1. Concurrent use of non-insulin therapies aimed to control hyperglycemia or use within the past 30 days of screening MMTT (V-2).

2. History of severe reaction or anaphylaxis to human, humanized or murine monoclonal antibodies.

3. Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT or AST> 1.5 x the upper limit of age-determined normal (ULN) .

4. Females who are pregnant or lactating.

5. Receipt of an immune modulating biologic or investigational drug within 3 months or 5 half-lives before enrollment.

6. History of other clinically significant autoimmune disease needing chronic therapy with biologics or steroids with the exception of celiac and stable thyroid disease.

7. Current use of any medication known to significantly influence glucose tolerance (e.g. oral steroids, atypical antipsychotics, diphenylhydantoin, niacin).

8. Any medical or psychological condition that in the opinion of the principal investigator would interfere with the safe completion of the trial.

9. For Study A (liraglutide)

1. Any history of pancreatitis or elevated amylase or lipase.

2. Any personal or family history of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC).

3. Any personal or family history of multiple endocrine neoplasia syndrome type 2.

4. Hypersensitivity to liraglutide.

5. Previous treatment with liraglutide.

6. Known history of clinically significant gastroparesis.

10. For Study B (golimumab)

1. Any history of recent (within 3 months) serious bacterial, viral, fungal, or other opportunistic infections.

2. Any history of demyelinating diseases (such as multiple sclerosis), heart failure, or left ventricular dysfunction.

3. Serologic evidence of current or past HIV, Hepatitis B, or Hepatitis C.

4. Positive QuantiFERON or PPD TB test, history of tuberculosis, or active TB infection.

5. Active infection with EBV, defined by real-time PCR.

6. Active infection with CMV, defined by real-time PCR.

7. Any of the following hematologic abnormalities at screening:

White blood count <3,000/μL or >14,000/μL
Lymphocyte count <500/μL
Platelet count <140,000 /μL
Hemoglobin <8.5 g/dL
Neutrophil count <2,000 cells/μL

8. Receipt of live vaccine (in the 6 weeks before treatment)

Endpoints (1)

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

1 endpoint
Primary/protocol endpoint

Proportion of individuals with peak MMTT stimulated C-peptide >0.017 pmol/mL.

Time frame:0-to-8 weeks

threshold achievement, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.