GLP-1 Peptide Atlas, by Delfa

UnknownPhase 1, PHASE2

Safety and Efficacy of Umbilical Cord Blood Regulatory T Cells Plus Liraglutide on Autoimmune Diabetes

Phase 1/ Phase 2 Study of the Therapeutic Effect of Ex-vivo Expanded Umbilical Cord Blood Regulatory T Cells With Liraglutide on Autoimmune Diabetes

Lead sponsor

Second Xiangya Hospital of Central South University

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•Treatment-emergent AEs (any)

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 IDNCT03011021

Org study ID0001

Timeline

Milestones

Study first posted2017-01-05estimated

Last update posted2023-03-14actual

Study start2017-01 (month precision)

Primary completion2025-06estimated (month precision)

Study completion2025-06estimated (month precision)

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Type 1 diabetes according to ADA criteria <3 years.

•Age≥ 18 years.

•Positive for at least one of the anti-islet autoantibodies: GADA, IA2A, ZnT8A

•Fasting or postprandial plasma C-peptide more than 100 pmol/L

•Written informed consent from the patient or family representative.

Exclusion criteria

•History or family history of medullary thyroid carcinoma or MEN 2 syndrome;

•History of chronic or acute pancreatitis;

•Allergic to liraglutide or any components in Victoza®;

•Hepatic abnormalities (transaminase > 2 times normal);

•Renal impairments (serum creatinine >133 umol/L);

•Cardiovascular diseases (hypertension, coronary heart disease, etc.);

•Presence of anemia (Hb ≤100g/L), leukopenia (<3.5×109/L);

•Presence of disorder in coagulation or anticoagulation, or thrombocytopenia (platelets <100×109/L);

•Presence of acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;

•Presence of any kind of chronic infection or immune deficiency, including hepatitis B, hepatitis C, HIV, syphilis or tuberculosis, etc.;

•Chronic use of systemic glucocorticoids or other immunosuppressive agents for over 3 months;

•Any history of malignancy;

•Female patients who are pregnant or breastfeeding; any female who is unwilling to use a reliable and effective form of contraception for 2 years after recruitment;

•Presence of any infectious diseases, including active skin infections, flu, fever, upper or lower respiratory tract infections; those who wish to participate in the study should keep the infection under control for at least 1 week before receiving Treg product infusion;

•Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.

Endpoints (9)

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

Safety / tolerability / PK

Other (unclassified)

Patient-reported / QoL

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in HbA1C

Time frame:2 years

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in C-peptide

Time frame:2 years

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin dose

Time frame:2 years

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Life quality evaluation

Time frame:2 years

threshold achievement, improvement

Safety / tolerability / PK

3 endpoints

Primary/protocol endpoint

Adverse effects

Time frame:2 years

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Hypoglycaemic events

Time frame:2 years

threshold achievement, event

Secondary/protocol endpoint

Change in titer of autoantibodies

Time frame:2 years

Immunogenicity (ADA)

change from baseline, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in immune cells diversities and quantities.

Time frame:2 years

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in autoimmune-related cytokines

Time frame:2 years

change from baseline, descriptive

Publications (6)

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

Glucagon-like peptide-1 prevents methylglyoxal-induced apoptosis of beta cells through improving mitochondrial function and suppressing prolonged AMPK activation.
Scientific reports2016 Mar 21PMID26997114doi:10.1038/srep23403via CT.gov background
G-CSF and Exenatide Might Be Associated with Increased Long-Term Survival of Allogeneic Pancreatic Islet Grafts.
PloS one2016 (year)PMID27285580doi:10.1371/journal.pone.0157245via CT.gov background
Glucagon-like peptide-1: modulator of β-cell dysfunction and death.
Diabetes, obesity & metabolism2013 Sep (month)PMID24003936doi:10.1111/dom.12165via CT.gov background
Multiple unit pooled umbilical cord blood is a viable source of therapeutic regulatory T cells.
Transplantation2013 Jan 15PMID23263503doi:10.1097/TP.0b013e31827722edvia CT.gov background
Comparative study of regulatory T cells expanded ex vivo from cord blood and adult peripheral blood.
Immunology2012 Jun (month)PMID22348606doi:10.1111/j.1365-2567.2012.03573.xvia CT.gov background
Infusion of ex vivo expanded T regulatory cells in adults transplanted with umbilical cord blood: safety profile and detection kinetics.
Blood2011 Jan 20PMID20952687doi:10.1182/blood-2010-07-293795via CT.gov background

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.