drugset

drugset / Trial / NCT04141423

Evaluation of Pharmacokinetics , Safety, Tolerability and Pharmacodynamics of Biocon Insulin Tregopil

NCT04141423 ↗

Phase 1 Terminated 55 enrolled Biocon Limited Juvenile Diabetes Research Foundation · collab Profil Institut für Stoffwechselforschung GmbH · collab

Non-randomizedSequentialOpen-labelTreatment

Summary

Multi-centre, open label, multiple ascending dose trial in patients with type 1 diabetes mellitus

Timeline

Start: 2019-10-28
Primary completion: 2021-04-23
Completion: 2021-04-23

Publications

Latres E, Plum-Moerschel L, Murugesan SMN, Lou O, Panda J, Marwah A, Samsonraj R, Gopu CL, Loganathan S, Athalye SN. 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. 2025 Jun;27(6):3154-3164. doi: 10.1111/dom.16327. Epub 2025 Apr 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Insulin Tregopil	Protein / enzyme biologic	30 mg	Oral
Comparator	Insulin Tregopil	Protein / enzyme biologic	45 mg	Oral
Comparator	Insulin Tregopil	Protein / enzyme biologic	60 mg	Oral

Indications