TerminatedPhase 4Results posted

Regulation of Insulin Secretion by the GLP-1 Receptor

Lead sponsor

VA Office of Research and Development

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Obesity / overweight, Prediabetes / glucose intolerance, Type 2 diabetes

Eligibility highlights

•BMI ≤35•HbA1c ≤5.7%•Healthy volunteers

Primary endpoints

•AIM2•AIM3

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 IDNCT02844907

Org study IDENDA-006-15S

Secondary ID01992Durham VA Medical Center

Secondary IDPro00070325Duke University

Timeline

Milestones

Study first posted2016-07-26estimated

Study start2018-07-01actual

Primary completion2021-12-31actual

Study completion2021-12-31actual

Last update posted2024-12-12actual

Results first posted2024-12-12actual

Assets

Investigational agents

Exenatide

Who this study enrolls

Healthy volunteersObesity / overweightPrediabetes / glucose intoleranceType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

AIM2: SELECTION OF HEALTHY SUBJECTS

•Healthy adults age 20-45 years

•Body Mass Index (BMI) less than or equal to 35.0 kg/m2

•HbA1c less than or equal to 5.7% as measured at screening visit

•Ability to speak and understand English

AIM3: NON-DIABETIC SUBJECTS

•Adults age 18-65 years

•Body Mass Index (BMI) 25-40.0 kg/m2

•HbA1c less than or equal to 6.5% as measured at screening visit

•No Diabetes or use of diabetes medications such as insulin or metformin

•Ability to speak and understand English

AIM3: DIABETIC Type II SUBJECTS

•Adults age 18-65 years

•Body Mass Index (BMI) 25-40.0 kg/m2

•HbA1c less than or equal to 7.5% plus a diagnosis of Type II diabetes managed by either Metformin, Sulfonylurea, or diet and exercise

•Ability to speak and understand English

Exclusion criteria

AIM2:

•Uncontrolled high blood pressure

•Diabetes or use of diabetes medications such as insulin or metformin

•Evidence of active heart disease, unstable angina or heart failure

•Lung disease or COPD

•Malabsorptive GI disease, such as celiac disease, or gastric bypass

•Significant hepatic disease

•Kidney disease or renal insufficiency (eGFR < 60 mL/kg/min)

•Untreated anemia (hematocrit < 34%) as measured at screening visit

•Pregnant females

•Active substance abuse

•Chronic use of oral steroid medications such as prednisone and hydrocortisone

•Apparent sensitivity to any study peptides as determined by the skin test

•Diagnosis or h/o PTSD

•Active mental health disorders such as depression, or as a result of Traumatic Brain Injury (TBI)

AIM3: ALL SUBJECTS

•Uncontrolled high blood pressure

•Evidence of active heart disease, unstable angina or heart failure

•Lung disease or COPD

•Malabsorptive GI disease, such as celiac disease, or gastric bypass

•Significant hepatic disease

•Kidney disease or renal insufficiency (eGFR < 60 mL/kg/min)

•Untreated anemia (hematocrit < 34%) as measured at screening visit

•Pregnant females

•Active substance abuse

•Chronic use of oral steroid medications such as prednisone and hydrocortisone

•Apparent sensitivity to any study peptides as determined by the skin test

•Diagnosis or h/o PTSD

•Active mental health disorders such as depression, or as a result of Traumatic Brain Injury (TBI)

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

AIM2: C-peptide Levels.

Time frame:Minute infusion periods (0-60 vs 60-120) baseline and treatment (Dex vs no Dex)

descriptive

Posted result

Group	Mean · ng/ml	95% CI
Hyperglycemic Clamp + Exendin (9-39)Control + exendin-(9-39)	10,335	-
Dexamethasone + exendin-(9-39)	9042	-

Primary/protocol endpoint/low confidence

AIM3: To Determine the Fasting GLP-1 Effect.

Time frame:Minute infusion periods (0-60 vs 60-120)

change from baseline, improvement

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.