Two-Way Crossover Phase 1 Bioequivalence and Safety Studies in Healthy Adults for a Ready-to-Use, Room-Temperature, Liquid-Stable Glucagon Administered by Autoinjector, Prefilled Syringe, or Vial and Syringe
Authors' conclusion
Bioequivalence and safety were established after 1 mg of this ready-to-use room-temperature liquid-stable glucagon, administered SC to healthy adults, by autoinjector, prefilled syringe, or vial and syringe kit.
Study context
- Population
- Healthy adults; ready-to-use room-temperature liquid-stable glucagontwo crossover studies
- Participants
- 32 / 40 / 72
- Comparison
- Glucagon autoinjector (GAI) or vial and syringe kit (GVS) vs glucagon prefilled syringe (G-PFS)
- GAIn = 32
- GVSn = 40
- G-PFSn = 72reference
- Primary endpoint
- Bioequivalence: geometric mean ratio of plasma glucagon AUC0-240 and Cmax within 80%–125%
- Follow-up
- 0 to 240 minutes
Methodological detailstwo-way crossover, two studies
- Two-way crossover
- Two studies
Primary result
As reported in the abstract
- G-PFS vs GAI: 90% CI 95.05%–119.67%
- G-PFS vs GAI: 90% CI 88.01%–120.24%
- GVS vs G-PFS: 90% CI 87.39%–100.66%
- GVS vs G-PFS: 90% CI 89.08%–106.08%
Safety
≥1 AE
- ≥1 AE — Mild adverse events (AEs)
- 69 of 73 (94.5%)
- ≥1 AE — Serious AEs
- 0
- ≥1 AE — Nausea (most common AE)
- 33/73 [45%]
Original publication
Two-Way Crossover Phase 1 Bioequivalence and Safety Studies in Healthy Adults for a Ready-to-Use, Room-Temperature, Liquid-Stable Glucagon Administered by Autoinjector, Prefilled Syringe, or Vial and Syringe. J Diabetes Sci Technol. Published 8 June 2023. doi:10.
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