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A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naive and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

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Trial Profile

A Phase III Randomized, Double-blind, Parallel Group Study to Evaluate the Efficacy and Safety of Once Daily Oral Administration of BI 10773 25 mg/Linagliptin 5 mg and BI 10773 10 mg/Linagliptin 5 mg Fixed Dose Combination Tablets Compared With the Individual Components (BI 10773 25 mg, BI 10773 10 mg, and Linagliptin 5 mg) for 52 Weeks in Treatment naive and Metformin Treated Patients With Type 2 Diabetes Mellitus With Insufficient Glycaemic Control

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2021

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At a glance

  • Drugs Empagliflozin/linagliptin (Primary) ; Empagliflozin; Linagliptin
  • Indications Type 2 diabetes mellitus
  • Focus Registrational; Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals

Most Recent Events

  • 15 Jun 2018 Results of pooled datea from two 52-week Phase III studies assessing the safety and tolerability of empagliflozin/linagliptin compared with their individual components published in the Advances in Therapy
  • 22 Nov 2016 According to a Boehringer Ingelheim media release, the European Commission has granted marketing authorization to Glyxambi (empagliflozin/linagliptin) for use in adults with type 2 diabetes (T2D). The approval is based on results from this and other two phase III trials (see profile 700226645 and 700228368).
  • 16 Sep 2016 According to a Boehringer Ingelheim Pharmaceuticals media release, the Committee for Medicinal Products for Human Use of the European Medicines Agency today recommended the approval of Glyxambi (empagliflozin/linagliptin) for use in adults with type 2 diabetes. Data from this and other two phase III trials supported this recommendations.

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