CompletedPhase NAResults posted

Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia

Role of Glucagon-Like Peptide-1 in Postprandial Hypoglycemia After Nissen Fundoplication: Studies With the GLP-1 Receptor Antagonist Exendin-(9-39)

Lead sponsor

Diva De Leon

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Eligibility highlights

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01162499

Org study ID09-007372

Timeline

Milestones

Study first posted2010-07-14estimated

Results first posted2016-11-09estimated

Last update posted2017-10-23actual

Study start2010-04 (month precision)

Primary completion2014-12actual (month precision)

Study completion2014-12actual (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age6 Months

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Children (6 months-18 years) who have had fundoplication or other gastric surgeries, irrespective of duration of postoperative period

•Weight > 6.5 Kg

•Signs and/or symptoms of PPH: post-prandial blood glucose levels of < 70 mg/dL ; symptoms including but not limited to feeding difficulties, irritability, nausea, diarrhea, pallor, diaphoresis, weakness, and lethargy after meals

Exclusion criteria

•Evidence of a medical condition that might alter results or compromise the elimination of the peptide, including, but not limited to: active infection, kidney failure (creatinine ≥ 2x above upper limit for age), severe liver dysfunction (AST or ALT ≥ 5x upper limit of normal for AST or ALT), severe respiratory or cardiac failure

•Other disorders of glucose regulation such as diabetes mellitus, congenital hyperinsulinism, glycogen storage disease

•Current use (within 1 week) of medications that may alter glucose homeostasis such as glucocorticoids, diazoxide, octreotide

•Use of antihistaminics within 10 days prior to the study

•Moderate and severe anemia defined as a hemoglobin < 10g/dL

•Pregnancy

•Milk and soy protein allergy

Endpoints (0)

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.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.