Endogenous HyperinsulinismFASTNCT04909333
Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
A study testing Exenatide and 0.9% saline solution in people with Endogenous Hyperinsulinism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endogenous Hyperinsulinism
- What is being tested?
- Exenatide and 0.9% saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- 29 Apr 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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
Who cannot join
- 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 %)
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Nuclear Medicine
Basel, 4031
About this study
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).
Read the detailed description
Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.
Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.
This study is to investigate the concept of the exenatide test to diagnose EHH.
- Conditions
- Endogenous Hyperinsulinism
- Being tested
- Exenatide, 0.9% saline solution
- Keywords
- fasting test, Blood glucose, insulin, proinsulin, C-peptide, betahydroxybutyrate, hypoglycemia
- Medical subject headings
- Hyperinsulinism, Insulin Resistance, Diabetes Mellitus, Insulin-Dependent, 2, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExenatideDrug
Also called Day 1 Exenatide; Day 2 : 0.9% saline solution
Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.
Day2:
The procedure is equal to study day 1. Instead of Exenatide, a 10ml 0.9% saline solution will be administered intravenously.
0.9% saline solutionDrug
Also called Day 1 : 0.9% saline solution, Day 2 Exenatide
Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.
Day2:
The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Group A (EHH Patients) | Experimental | Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2. Receives: Drug: Exenatide; Drug: 0.9% saline solution |
| Group B (EHH Patients) | Experimental | Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2. Receives: Drug: Exenatide; Drug: 0.9% saline solution |
| Group C (control subjects) | Experimental | Control subjects without evidence for EHH defined by no glucose levels below 3.0 mmol/l during a 7-day CGFS (Freestyle libre) and matched to EHH patients for age, gender and BMI will receive only on one study day a single intravenous injection of 10μg Exenatide and compared to group A patients on Day 2. They will not receive a Placebo injection. Receives: Drug: Exenatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to symptomatic hypoglycemia after exenatide test compared to placebo
time to symptomatic hypoglycemia after exenatide test compared to placebo
Measured: within 4 hours after injection
Secondary outcomes (11)
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection
Measured: within 4 hours after injection
time to symptoms
time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution
Measured: within 4 hours after injection
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the placebo
Measured: within 4 hours after injection
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test
time to hypoglycemia (time to reach blood sugar level ≤ 2.5 mmol/l) in the exenatide test in comparison to the fasting test
Measured: within 4 hours after injection
time to symptoms in the exenatide test in comparison to the fasting test
time to symptoms in the exenatide test in comparison to the fasting test
Measured: within 4 hours after injection
change in levels of plasma glucose compared to placebo compared to placebo
change in levels of plasma glucose compared to placebo
Measured: within 4 hours after injection
change in levels of insulin compared to placebo
change in levels of insulin compared to placebo
Measured: within 4 hours after injection
change in levels of C-peptide compared to placebo
change in levels of C-peptide compared to placebo compared to placebo
Measured: within 4 hours after injection
change in levels of proinsulin compared to placebo
change in levels of proinsulin compared to placebo
Measured: within 4 hours after injection
change in levels of ß-hydroxybutyrate compared to placebo
change in levels of ß-hydroxybutyrate compared to placebo
Measured: within 4 hours after injection
costs of exenatide test setting (CHF)
Comparison of costs of exenatide test setting with fasting test setting
Measured: within 4 hours after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start29 Apr 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endogenous HyperinsulinismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, single-center, cross-over, placebo controlled pilot, proof of principle clinical study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Responsible party
- Sponsor
- Investigators
- Emanuel Christ, Prof. Dr. med., Study director, University Hospital of Basel, Interdisciplinary Endocrinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04909333
- Sponsor's protocol ID
- 2020-00169; qu20Antwi2
- Acronym
- FAST
- Status last verified
- May 2024
- First submitted
- 26 May 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hepprich M, Romberg C, Mudry J, Refardt J, Wild D, Antwi K, Christ E. Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study. Eur J Endocrinol. 2025 Jul 31;193(2):247-254. doi: 10.1093/ejendo/lvaf153.
PubMed 40747712
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia
- ClinicalTrials.gov ID
- NCT04909333
- Acronym / sponsor ID
- FAST / 2020-00169; qu20Antwi2
- Conditions
- Endogenous Hyperinsulinism
- Keywords
- fasting test, Blood glucose, insulin, proinsulin, C-peptide, betahydroxybutyrate, hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Gottfried und Julia Bangerter- Rhyner-Stiftung, Basel
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the concept of the exenatide test for diagnosis of EHH (earlier induction of symptomatic hypoglycemia compared to placebo within 4 hours after injection).
Detailed description
Endogenous hyperinsulinemic hypoglycemia (EHH) is defined as inappropriate endogenous insulin secretion leading to hypoglycemia and associated symptoms. The most frequent diagnosis is an insulin-secreting pancreatic neuroendocrine tumor, but other diagnoses such as nesidioblastosis of the pancreatic islets are also possible. Biochemically, EHH is characterized by low glucose concentrations in the presence of inappropriately increased C-peptide (endogenous insulin secretion) and insulin levels. The conventional fasting test is at present the gold standard to document EHH.
Radiolabeled Exenatide for localizing insulinomas in patients with biochemically proven EHH has been evaluated and an exenatide-test in an outpatient setting may be able to replace the fasting test, by an early symptomatic hypoglycemia compared to a prolonged inpatient monitoring.
This study is to investigate the concept of the exenatide test to diagnose EHH.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Prospective, single-center, cross-over, placebo controlled pilot, proof of principle clinical study
| Arm | Type | Receives |
|---|---|---|
| Group A (EHH Patients) | Experimental | Drug: Exenatide, Drug: 0.9% saline solutionGroup A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2. |
| Group B (EHH Patients) | Experimental | Drug: Exenatide, Drug: 0.9% saline solutionGroup B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2. |
| Group C (control subjects) | Experimental | Drug: ExenatideControl subjects without evidence for EHH defined by no glucose levels below 3.0 mmol/l during a 7-day CGFS (Freestyle libre) and matched to EHH patients for age, gender and BMI will receive only on one study day a single intravenous injection of 10μg Exenatide and compared to group A patients on Day 2. They will not receive a Placebo injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExenatideAlso: Day 1 Exenatide; Day 2 : 0.9% saline solutionDay1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed. Day2: The procedure is equal to study day 1. Instead of Exenatide, a 10ml 0.9% saline solution will be administered intravenously. | Drug | Group A (EHH Patients), Group B (EHH Patients), Group C (control subjects) |
| 0.9% saline solutionAlso: Day 1 : 0.9% saline solution, Day 2 ExenatideDay1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 2 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed. Day2: The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously. | Drug | Group A (EHH Patients), Group B (EHH Patients) |
Primary outcome
time to symptomatic hypoglycemia after exenatide test compared to placebo
Time frame: within 4 hours after injection
time to symptomatic hypoglycemia after exenatide test compared to placebo
11 secondary outcomes
time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l))
Time frame: within 4 hours after injection
time to symptoms
Time frame: within 4 hours after injection
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
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
time to symptoms in the exenatide test in comparison to the fasting test
Time frame: within 4 hours after injection
change in levels of plasma glucose compared to placebo compared to placebo
Time frame: within 4 hours after injection
change in levels of insulin compared to placebo
Time frame: within 4 hours after injection
change in levels of C-peptide compared to placebo
Time frame: within 4 hours after injection
change in levels of proinsulin compared to placebo
Time frame: within 4 hours after injection
change in levels of ß-hydroxybutyrate compared to placebo
Time frame: within 4 hours after injection
costs of exenatide test setting (CHF)
Time frame: within 4 hours after injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 40747712Hepprich M, Romberg C, Mudry J, Refardt J, Wild D, Antwi K, Christ E. Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study. Eur J Endocrinol. 2025 Jul 31;193(2):247-254. doi: 10.1093/ejendo/lvaf153.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emanuel Christ, Prof. Dr. med. study director
University Hospital of Basel, Interdisciplinary Endocrinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exenatide and 0.9% saline solution in people with Endogenous Hyperinsulinism, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to symptomatic hypoglycemia after exenatide test compared to placebo (time frame: within 4 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04909333, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.