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Trial · Interventional

CompletedNot applicableRegistry data

Exenatide-test for Diagnosing Endogenous Hyperinsulinemic Hypoglycemia

Short name FAST

NCTNCT04909333 (opens ClinicalTrials.gov in a new tab)Other id2020-00169; qu20Antwi2
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
29 participants (actual)
Sponsor
University Hospital, Basel, Switzerland · Other
Design
Randomized · Double masking
Countries
1 country

Switzerland

Start
29 Apr 2021
Primary completion
30 Apr 2024
Completion
30 Apr 2024
First posted
1 Jun 2021
Last update posted
8 May 2024
Conditions
Endogenous Hyperinsulinism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. N/A

    FAST

    NCT04909333

    29 Apr 2021 to 30 Apr 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • ExenatideDrug
  • 0.9% saline solutionDrug

Arms3

  • Experimental

    Group A (EHH Patients)

    Group A will receive a placebo injection (0.9% saline solution) on Day 1 and 10μg Exenatide injection on Day 2.

  • Experimental

    Group B (EHH Patients)

    Group B will receive a 10μg Exenatide injection on Day 1 and placebo injection (0.9% saline solution) on Day 2.

  • Experimental

    Group C (control subjects)

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. time to symptomatic hypoglycemia after exenatide test compared to placebo

    Time frame · within 4 hours after injection

    Registry description

    time to symptomatic hypoglycemia after exenatide test compared to placebo

Secondary outcomes(11)

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

    Time frame · within 4 hours after injection

    Registry description

    time dependent decrease (time Δ from injection in min) of blood glucose (% or mmol/l)) that can best discriminate from placebo injection

  2. time to symptoms

    Time frame · within 4 hours after injection

    Registry description

    time to symptoms of the exenatide test in comparison to the placebo injection of 10ml 0.9% saline solution

  3. 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

    Registry description

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

  4. 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

    Registry description

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

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

    Time frame · within 4 hours after injection

    Registry description

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

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

    Time frame · within 4 hours after injection

    Registry description

    change in levels of plasma glucose compared to placebo

  7. change in levels of insulin compared to placebo

    Time frame · within 4 hours after injection

    Registry description

    change in levels of insulin compared to placebo

  8. change in levels of C-peptide compared to placebo

    Time frame · within 4 hours after injection

    Registry description

    change in levels of C-peptide compared to placebo compared to placebo

  9. change in levels of proinsulin compared to placebo

    Time frame · within 4 hours after injection

    Registry description

    change in levels of proinsulin compared to placebo

  10. change in levels of ß-hydroxybutyrate compared to placebo

    Time frame · within 4 hours after injection

    Registry description

    change in levels of ß-hydroxybutyrate compared to placebo

  11. costs of exenatide test setting (CHF)

    Time frame · within 4 hours after injection

    Registry description

    Comparison of costs of exenatide test setting with fasting test setting

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

7 results

Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study.

Hepprich et al. 2025European journal of endocrinologycited by 2

PMID 40747712DOI 10.1093/ejendo/lvaf153PUB-40747712

Full text at the publisher7 results
Publisher pageSee results (7)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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