CompletedPhase 2Results posted

Gastrointestinal Sensorimotor Dysfunctions in Diabetes Mellitus

Lead sponsor

Mayo Clinic

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

104

Study population

Eligibility highlights

•Healthy volunteers

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 IDNCT02170870

Org study ID14-002098

Secondary IDP01DK068055

Timeline

Milestones

Study first posted2014-06-23estimated

Primary completion2017-11-17actual

Study completion2017-11-17actual

Last update posted2019-04-23actual

Results first posted2019-04-23actual

Study start2014-06 (month precision)

Assets

Investigational agents

Avexitide

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

for controls:

•Healthy male or non-pregnant, non-breastfeeding female volunteers;

•18-70 years old;

•Able to provide written informed consent before participating in the study;

•Able to communicate adequately with the investigator and to comply with the requirements for the entire study

Additional inclusion criteria for patients:

•Symptoms of dyspepsia (i.e., early satiety, postprandial discomfort, nausea, vomiting, regurgitation)

•Patients in the Diabetes Mellitus (DM) group will also require Type 1 or 2 DM of ≥ 3 years duration; in patients with type 2 DM, the dyspepsia symptoms should have begun or worsened after DM was diagnosed

Exclusion criteria

•for patients and controls:

•Major abdominal surgery (i.e., appendectomy, cholecystectomy, tubal ligation, hysterectomy, and limited colonic resection are permissible)

•Clinical evidence (including physical exam and EKG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns

•Opiates, alpha adrenergic agonists, metoclopramide, and high doses of anticholinergic agents (e.g., amitriptyline greater than 50 mg daily). If medically safe, these drugs may be discontinued for four half lives prior to study assessments

•Treatment with glucagon-like peptide-1 (GLP-1) agonists and amylin which cause vagal blockade and may affect central processing of pain

•Use of tobacco products within the past six months or NSAIDs or aspirin within the past week (since they all may affect intestinal permeability)

•Bleeding or clotting disorders or medications that increase risk of bleeding from mucosal biopsies

•Positive tissue transglutaminase antibodies (TTG)

•For two days prior to studies, subjects will be instructed to avoid ingestion of artificial sweeteners such as sucralose (SplendaTM), aspartame (NutrasweetTM), foods containing lactulose or mannitol

•Pregnant or breast-feeding females

•Known intolerance or allergy to eggs

•Poor peripheral venous access, if central venous access is not available

•Any other condition or prior therapy that, in the opinion of the investigator, would make the patient unsuitable for the study

Exclusion criteria for controls only:

• Current symptoms of a functional gastrointestinal disorder assessed by questionnaire

Exclusion criteria for patients only:

•Severe vomiting that would preclude tube placement or participation in the study

•Structural cause for symptoms by endoscopy within the past 48 months

•Patients with gastric pacemakers

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.