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Targeting Beta Cell Dysfunction With Liraglutide or Golimumab in Longstanding T1D
Targeting Beta Cell Dysfunction in Longstanding T1D
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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:
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 endpointProportion 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
- PloS one2023 (year)PMID38096190doi:10.1371/journal.pone.0293268via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.