A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Trial Profile

A 78 Week Open Label Extension to Trials Assessing the Safety and Efficacy of BI 1356 (5 mg) as Monotherapy or in Combination With Other Antidiabetic Medications in Type 2 Diabetic Patients.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Mar 2017

At a glance

  • Drugs Linagliptin (Primary) ; Metformin; Pioglitazone; Sulfonylureas
  • Indications Type 2 diabetes mellitus
  • Focus Adverse reactions; Registrational
  • Acronyms OLE
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 31 May 2016 According to Boehringer Ingelheim media release, the U.S. Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended-release) tablets for the treatment of type 2 diabetes (T2D) in adults.
    • 12 Jun 2012 Results published in International Journal of Clinical Practice.
    • 08 Dec 2011 Results were presented at the 21st Congress of the International Diabetes Federation (IDF).
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