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

NCT04141423 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-06-27

No results posted yet for this study

Summary

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

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.

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Biocon Limited

    lead INDUSTRY

Principal Investigators

  • Ulrike Hövelmann, MD · Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9 (Acting as Coordinating Investigator)

  • Leona Plum Mörschel, MD · Profil Institut für Stoffwechselforschung GmbH Hellersbergstraße 9

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-28
Primary Completion
2021-04-23
Completion
2021-04-23
FDA Drug
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141423 on ClinicalTrials.gov