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

PHASE1TerminatedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

October 28, 2019

Primary Completion Date

April 23, 2021

Study Completion Date

April 23, 2021

Conditions
Type 1 Diabetes Mellitus (T1DM)
Interventions
DRUG

Tregopil

Insulin Tregopil is recombinant human insulin modified by a single amphiphilic oligomer covalently linked via an amide bond to lysine at position 29 of the B-chain. This alters the physicochemical characteristics of the molecule, leading to enhanced stability and resistance to intestinal degradation following oral administration.

Trial Locations (1)

Unknown

Profil Mainz GmbH & Co. KG Malakoff-Passage,Rheinstraße 4C D-55116, Mainz

Sponsors
All Listed Sponsors
collaborator

Profil Institut für Stoffwechselforschung GmbH

INDUSTRY

collaborator

Juvenile Diabetes Research Foundation

OTHER

lead

Biocon Limited

INDUSTRY