GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

Study of the Acute Metabolic Effect of Exenatide in Type 1 Diabetes

A Pilot Study to Determine the Effects of a Single Dose of Exenatide (Byetta ®) on the Acute Metabolic Responses to a Mixed Meal or Intravenous Glucose Tolerance Test in Patients With Type 1 Diabetes

Lead sponsor

Yale University

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Type 1 diabetes

Key I/E criterion

—

Primary endpoint

•Effect of exenatide on metabolic responses to an oral (as a mixed meal)

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 IDNCT01855490

Org study ID1201009520

Timeline

Milestones

Study first posted2013-05-16estimated

Last update posted2016-07-07estimated

Study start2012-01 (month precision)

Primary completion2013-07actual (month precision)

Study completion2013-10actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age56 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•T1D of at least 3 yrs duration.

•Male or female aged 18-56 years who meets the American Diabetes Association standard T1DM criteria.

•HgbA1c<9%

•Insulin requirement of < 0.8 U/kg/d

•Absence of severe hypoglycemia in the past 6 months

•Absence of ketoacidosis in the past 6 months

•Menstruating women must have a negative pregnancy test and be willing to avoid pregnancy during the study period.

•Signed informed consent..

Exclusion criteria

•Inability or unwillingness to give informed consent.

•Prior Exenatide or Liraglutide treatment or use of any medication that could potentially affect diabetes or immunologic status

•Known hypersensitivity to Exenatide or any product components

•Participation in an investigational treatment trial within the last 6 weeks before enrollment.

•Any medical condition that in the opinion of the investigator would interfere with safe completion of the trial such as: epilepsy, atopic disease, active Grave's disease, cystic fibrosis, sickle cell anemia, neuropathy, peripheral vascular disease, cerebrovascular disease,liver disease, HIV, or any concurrent autoimmune disease except treated and stable thyroid disease

•Known severe renal impairment, end-stage renal disease or renal transplantation.

•Any history of gastroparesis or other severe gastrointestinal disease, pancreatitis, thyroid nodules or malignancy with the exclusion of a history of localized basal cell carcinoma.

•Uncompensated heart failure, fluid overload, myocardial infarction or liver disease within the last 6 weeks before enrollment.

•Active clinically serious infections.

•Positive pregnancy test in menstruating women or lactating females

Endpoints (2)

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.

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint/low confidence

Effect of exenatide on metabolic responses to an oral (as a mixed meal) or intravenous glucose challenge in subjects with established T1D with or without residual insulin production.

Time frame:Each patients is estimated to finish the study within 4-6 weeks

descriptive

Secondary/protocol endpoint/low confidence

Effect of exenatide on insulin secretion, glucagon secretion, GLP-1 and GIP levels, and gastric emptying in these patients with T1D. - effect of exenatide on residual insulin production

Time frame:4-6 weeks

change from baseline, improvement

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.