Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study
Authors' conclusion
Exenatide is a promising, faster, less cumbersome, and less expensive diagnostic tool for EHH compared to the fasting test. Larger trials are warranted to confirm its diagnostic utility.
Study context
- Population
- Patients with endogenous hyperinsulinemic hypoglycemia (EHH) confirmed in a fasting test, plus matched controlsEHH patients, cross-over
- Participants
- 14 patients
- Comparison
- 10 μg IV exenatide vs placebo
- Controlsn = 14
Methodological detailsprospective, placebo-controlled, double-blind, cross-over, proof-of-principle, Clinical monitoring and glucose, insulin, C-peptide and proinsulin measured for 4 h; EHH follow-up included imaging and histology
- Prospective
- Placebo-controlled
- Double-blind
- Cross-over
- Proof-of-principle
- Clinical monitoring and glucose, insulin, C-peptide and proinsulin measured for 4 h; EHH follow-up included imaging and histology
Primary result
As reported in the abstract
Diagnostic hypoglycemia in EHH patients · 4 h
Exenatide
42%
6 events
Placebo
0
events
P = 0.005
Further findings
| Outcome | Exenatide | Placebo | Controls | P value |
|---|---|---|---|---|
| Time to glucose nadir in EHH patientsExenatide vs Placebo · earlier with exenatide | 67 (95% CI 50–142) min | 210 (95% CI 174–219) min | — not stated in the abstract | P < 0.0001 |
| Glucose nadir level in EHH patientsExenatide vs Placebo · lower with exenatide | 2.68 (95% CI 2.26–3.02) mmol/L | 3.2 (95% CI 2.92–3.77) mmol/L | — not stated in the abstract | P < 0.0001 |
| Proinsulin 120 min post-exenatide, EHH patients vs controlsHigher in EHH patients | — not stated in the abstract | — not stated in the abstract | 9 (95% CI 4.5–16.9) pmol/L | P = 0.0001 |
| Time to hypoglycemia, exenatide vs fasting testShorter with exenatide | 1.38 (95% CI .67-2.99) h | — not stated in the abstract | — not stated in the abstract | P = 0.032 |
— not stated in the abstract
- Proinsulin 120 min post-exenatide, EHH patients vs controls: EHH patients 69 (95% CI 3.8–232) pmol/L
- Time to hypoglycemia, exenatide vs fasting test: Fasting test 12 (95% CI 1.44–36.1) h
Patient preference
- Exenatide preferred by patients over the fasting test
Safety
Tolerability
- Exenatide was well tolerated
Original publication
Exenatide for diagnosing endogenous hyperinsulinemic hypoglycemia: a randomized placebo-controlled, double-blind, cross-over proof-of-principle study. Eur J Endocrinol. Published 1 August 2025. doi:10.
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