An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies.
Phase of Trial: Phase III
Latest Information Update: 23 Jun 2016
At a glance
- Drugs Trelagliptin (Primary)
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Takeda
- 26 Mar 2015 According to Takeda Pharmaceuticals media release, based on the results of this and other phase III trials ( see profile 226639 and 219690), Japanese Ministry of Health, Labour and Welfare has approved the New Drug Application of Zafatek (trelagliptin succinate).
- 22 Sep 2011 Planned end date changed to 1 Jul 2013 as reported by ClinicalTrials.gov.
- 09 Sep 2011 New source identified and integrated (ClinicalTrials.gov: US National Institutes of Health; NCT01431807).