An Open Label, Multi-center, Randomized, Parallel Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Insulin Tregopil (IN-105) Compared With Insulin Aspart in the Treatment of Patients With Type 2 Diabetes Mellitus on Stable Dose of Metformin and Insulin Glargine

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Trial Profile

An Open Label, Multi-center, Randomized, Parallel Group Phase II/III Clinical Study to Evaluate the Efficacy and Safety of Insulin Tregopil (IN-105) Compared With Insulin Aspart in the Treatment of Patients With Type 2 Diabetes Mellitus on Stable Dose of Metformin and Insulin Glargine

Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 06 Mar 2018

At a glance

  • Drugs Insulin tregopil (Primary) ; Insulin aspart
  • Indications Type 2 diabetes mellitus
  • Focus Therapeutic Use
  • Sponsors Biocon

    • Most Recent Events

    • 06 Feb 2018 Status changed from not yet recruiting to recruiting.
    • 15 Dec 2017 Status changed from planning to not yet recruiting.
    • 06 Sep 2017 According to a Biocon media release, the company has filed Clinical Trial Application with the Indian regulator (DCGI) for a Phase II/III study with Insulin Tregopil in type 2 diabetes.
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