GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT03011008

UnknownPhase 4

Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

Effect of Liraglutide as Additional Treatment to Insulin in Patients With Autoimmune Diabetes Mellitus

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

•Mean amplitude of glycemic excursions (MAGE)

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 IDNCT03011008

Org study ID0002

Timeline

Milestones

Study first posted2017-01-05estimated

Last update posted2020-03-18actual

Study start2017-01 (month precision)

Primary completion2020-12estimated (month precision)

Study completion2021-06estimated (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 acute metabolic disorders; In the case of acute ketone acidosis, with blood ketone over 0.3mmol/L and pH lower than 7.30;

•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 (6)

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

Patient-reported / QoL

Safety / tolerability / PK

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Mean amplitude of glycemic excursions (MAGE)

Time frame:1 year

descriptive, improvement

Secondary/protocol endpoint

Change in HbA1C

Time frame:1 year

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in C-peptide

Time frame:1 year

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

Change in insulin dose

Time frame:1 year

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Life quality evaluation

Time frame:1 year

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint/low confidence

Hyperglycemic and hypoglycemic events

Time frame:1 year

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Postprandial glucose

Publications (3)

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
Glucagon-like peptide-1: modulator of β-cell dysfunction and death.
Diabetes, obesity & metabolism2013 Sep (month)PMID24003936doi:10.1111/dom.12165via CT.gov background
Arresting type 1 diabetes after diagnosis: GAD is not enough.
Lancet (London, England)2011 Jul 23PMID21715000doi:10.1016/S0140-6736(11)60978-1via 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.