DelfaGLP-1 Atlas

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CompletedPhase NA

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

—

Enrollment

29

actual

Study population

Diabetes (other / unspecified), Prediabetes / glucose intolerance

Key I/E criterion

—

Primary endpoint

•Symptomatic hypoglycemia after exenatide test

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 IDNCT04909333
Org study ID2020-00169; qu20Antwi2

Timeline

Milestones

Study start2021-04-29actual
Study first posted2021-06-01actual
Primary completion2024-04-30actual
Study completion2024-04-30actual
Last update posted2024-05-08actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Diabetes (other / unspecified)Prediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Patients with suspicion for an insulinoma fulfilling all of the following inclusion criteria are eligible for the study:

Inclusion Criteria:

•Informed Consent as documented by signature
•Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations (standardized 72h fasting test).).

Participants as control subjects fulfilling all of the following inclusion criteria are eligible for the study:

Inclusion Criteria:

•Informed Consent as documented by signature (Appendix Informed Consent Form)
•Possession of the adequate match criteria (age, BMI and gender) to patients with suspicion for an insulinoma

Exclusion criteria

•Known hypersensitivity or allergy to Exenatide
•Pregnant or breastfeeding female patients. A pregnancy test will be performed in all women of child bearing potential.
•Calculated creatinine clearance below 40 ml/min
•No signed informed consent
•Intake of any glucagon-like peptide (GLP)-1 analogue (such as Byetta® or Bydureon®[= Exenatide])
•prediabetes or diabetes (HbA1c > 5.7 %)
•Previous abdominal surgery in the gastrointestinal tract
•Any concomitant glucose-lowering drug (i. e. insulin, sulfonyl urea)
•Any known intolerance to standardized meal (Maizena)
•Any uncontrolled significant medical, psychiatric or surgical condition (active infection, unstable angina pectoris, cardiac arrhythmia, poorly controlled hypertension, uncontrolled congestive heart disease, etc.) or laboratory findings that might jeopardize the patient's safety or that would limit compliance with the objectives and assessments of the study.
•Any mental conditions which prevent the patient from understanding the type, extent and possible consequences of the study and/or an uncooperative attitude from the patient

Endpoints (12)

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.

Coverage by outcome category

Glycemic / diabetes
5
Safety / tolerability / PK
4
Other (unclassified)
3

Glycemic / diabetes

5 endpoints
Secondary/protocol endpoint

time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))

Time frame:within 4 hours after injection

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in levels of plasma glucose compared to placebo compared to placebo

Time frame:within 4 hours after injection

change from baseline, improvement

Secondary/protocol endpoint

change in levels of insulin compared to placebo

Time frame:within 4 hours after injection

change from baseline, improvement

Secondary/protocol endpoint

change in levels of C-peptide compared to placebo

Time frame:within 4 hours after injection

C-peptide AUC

change from baseline, improvement

Secondary/protocol endpoint

change in levels of proinsulin compared to placebo

Time frame:within 4 hours after injection

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

time to symptomatic hypoglycemia after exenatide test compared to placebo

Time frame:within 4 hours after injection

time to event, event

Secondary/protocol endpoint/low confidence

time to symptoms

Time frame:within 4 hours after injection

time to event, event

Secondary/protocol endpoint

time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo

Time frame:within 4 hours after injection

Documented hypoglycemia

time to event, event

Secondary/protocol endpoint

time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test

Time frame:within 4 hours after injection

Documented hypoglycemia

time to event, event

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

time to symptoms in the exenatide test in comparison to the fasting test

Time frame:within 4 hours after injection

time to event, descriptive

Secondary/protocol endpoint/low confidence

change in levels of ß-hydroxybutyrate compared to placebo

Time frame:within 4 hours after injection

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

costs of exenatide test setting (CHF)

Time frame:within 4 hours after injection

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.