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A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase III Clinical Trial for the Efficacy and Safety of Fugliglitinate Benzoate Tablets in Patients With Type 2 Diabetes Who Cannot be Effectively Controlled by Metformin

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Trial Profile

A Multi-center, Randomized, Double-blind, Placebo Parallel Controlled Phase III Clinical Trial for the Efficacy and Safety of Fugliglitinate Benzoate Tablets in Patients With Type 2 Diabetes Who Cannot be Effectively Controlled by Metformin

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2025

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At a glance

  • Drugs Fotagliptin (Primary) ; Metformin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Shenzhen Salubris Pharmaceuticals

Most Recent Events

  • 01 Jul 2025 Primary endpoint has been met. (HbA1c change from baseline at week 24), according to a results published in the Diabetes, Obesity and Metabolism.
  • 01 Jul 2025 Results assessing the efficacy and safety of fotagliptin add-on to metformin in patients with T2D published in the Diabetes, Obesity and Metabolism.
  • 07 Aug 2024 New source identified and integrated China Drug Trials (CTR20200061).

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