An open‐label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability
Authors' conclusion
Fixed-dose insulin Tregopil reduced the requirement for insulin aspart supplementation, although it was not a viable stand-alone option for the daily management of T1DM. Insulin Tregopil could be explored with a flexible dosing approach and be titrated based on individual needs.
Study context
- Population
- Patients with T1D on optimised basal-bolus insulin (glargine and aspart); 3 female (8.1%), 34 male (91.9%); median age 39.5 years
- Participants
- 37 patients
- Comparison
- Ascending doses of oral insulin Tregopil
- Outcome
- Safety and tolerability (AEs, hypo-/hyperglycaemic episodes, vital signs, ECGs, laboratory safety parameters, physical examination)
Methodological detailsopen-label
- Open-label
Main finding
As reported in the abstract
Severe hypoglycaemic episodes
0
Secondary outcomes
- Rapid onset; peak blood concentrations reached post-dosing within
- 15-20 min
- Pharmacodynamics (PD) effect lasted up to
- 105 min
- Variability of pharmacokinetics (PK)/PD parameters was in general high
Safety
Hypoglycaemia
- Incidence did not increase with increasing doses; none of the episodes were severe
- 0 severe
Original publication
An open‐label, multiple ascending dose trial of orally administered insulin Tregopil in patients with type 1 diabetes mellitus to evaluate its pharmacokinetics, pharmacodynamics, safety and tolerability. Diabetes Obes Metab. Published 10 April 2025. doi:10.
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