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A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 2 Diabetes

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Trial Profile

A Phase 3, Randomized, Open-Label, Multicenter, Active-controlled Trial Comparing Efficacy and Safety of THDB0206 Injection With Insulin Lispro Injection Combined With Insulin Glargine Injection U-100 in Chinese Participants With Type 2 Diabetes

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 May 2025

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At a glance

  • Drugs Insulin lispro (Primary) ; Insulin glargine
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Tonghua Dongbao Pharmaceutical

Most Recent Events

  • 17 Apr 2025 According to an Adocia media release, assuming successful Phase 3 results, Tonghua Dongbao plans on submitting Ultra-Rapid Insulin BioChaperone Lispro for Chinese regulatory review in 2025.
  • 12 Dec 2024 Status changed from recruiting to active, no longer recruiting, according to an Adocia media release.
  • 12 Dec 2024 According to an Adocia media release, The final dosing of the last Type 2 diabetes patient is associated with a milestone payment of $10 million to Adocia. This payment will be received in the second quarter of 2025 as per the payment terms of the Licensing Agreement.

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