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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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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

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 06 Dec 2022

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At a glance

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

    • Most Recent Events

    • 01 Nov 2022 Primary endpoint (Part II - To compare the efficacy of Insulin Tregopil versus IAsp in T2DM patients who are on stable dose of metformin and insulin glargine) has been met, as per results published in the Expert Opinion on Pharmacotherapy.
    • 01 Nov 2022 Results assessing the efficacy and safety of ultra-rapid acting oral prandial insulin Tregopil compared with insulin aspart in patients with type 2 diabetes on insulin glargine and metformin, published in the Expert Opinion on Pharmacotherapy.
    • 08 Jul 2019 Status changed from active, no longer recruiting to completed.

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