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An Open Label, Multiple Ascending Dose Trial in Patients With T1DM to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin Tregopil and to Evaluate the Postprandial Glucose Control With Different Meal Types in Comparison With Insulin Aspart

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Trial Profile

An Open Label, Multiple Ascending Dose Trial in Patients With T1DM to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin Tregopil and to Evaluate the Postprandial Glucose Control With Different Meal Types in Comparison With Insulin Aspart

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 29 Jun 2022

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At a glance

  • Drugs Insulin tregopil (Primary)
  • Indications Type 1 diabetes mellitus
  • Focus Adverse reactions; Therapeutic Use
  • Sponsors Biocon

    • Most Recent Events

    • 22 Jun 2022 Status changed from completed to discontinued.
    • 03 Mar 2022 Status changed from recruiting to completed.
    • 21 May 2021 The study protocol amended for the change in the evaluation of Biocon Insulin Tregopil. Earlier, the study involved a comparison of Biocon Insulin Tregopil and Insulin Aspart. Study endpoints were updated as a study is divided into two parts. The study phase changed from phase I to phase 1/phase 2. The number of treatment arms increased from 3 to 4.
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