CompletedPhase 3Results posted

Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

To Determine the Effect of Endogenous GLP-1 Secretion on Islet Function in People With and Without Type 2 Diabetes

Lead sponsor

Adrian Vella

Asset

Avexitide

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

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 IDNCT04466618

Org study ID20-003993

Secondary IDR01DK126206

Timeline

Milestones

Study first posted2020-07-10actual

Study start2021-04-15actual

Primary completion2022-12-15actual

Study completion2022-12-31actual

Last update posted2023-12-26actual

Results first posted2023-12-26actual

Assets

Investigational agents

Avexitide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age25 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•non-diabetic subjects:

•Weight-stable, non-diabetic subjects

Exclusion criteria

•non-diabetic subjects:

•Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).

•HbA1c ≥ 6.5%

•Use of glucose-lowering agents.

•For female subjects: positive pregnancy test at the time of enrollment or study

•History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.

•Active systemic illness or malignancy.

•Symptomatic macrovascular or microvascular disease.

Inclusion criteria - diabetic subjects:

•Weight-stable, diabetic subjects treated with diet and lifestyle alone or with metformin monotherapy

Exclusion Criteria - diabetic subjects:

•Age < 25 or > 65 years (to avoid studying subjects who could have latent type 1 diabetes, or the effects of age extremes in subjects with normal or impaired fasting glucose).

•Use of any glucose-lowering agent other than metformin.

•2 or more fasting glucose values > 250mg/dl on medication or after medication withdrawal.

•Unwillingness or inability to withdraw medication for three weeks prior to, and for the duration of the study.

•For female subjects: positive pregnancy test at the time of enrollment or study

•History of prior upper abdominal surgery such as adjustable gastric banding, pyloroplasty and vagotomy.

•Active systemic illness or malignancy.

•Symptomatic macrovascular or microvascular disease.

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.