Trial Profile
A phase III, randomized, double-blind, parallel group study to evaluate the efficacy and safety of linagliptin 5 mg compared to placebo, administered as oral fixed dose combination with empagliflozin 10 mg or 25 mg, in patients with type 2 diabetes mellitus and insufficient glycaemic control after 16 weeks of treatment with empagliflozin 10 mg or 25 mg on metformin background therapy
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 18 Jul 2017
Price :
$35
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At a glance
- Drugs Empagliflozin/linagliptin (Primary) ; Empagliflozin
- Indications Type 2 diabetes mellitus
- Focus Registrational; Therapeutic Use
- Sponsors Boehringer Ingelheim Pharmaceuticals; Unilfarma
- 13 Jun 2017 Results of a pooled analysis from two Phase III trials presented at the 77th Annual Scientific Sessions of the American Diabetes Association
- 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 700205423 and 700226645).
- 16 Sep 2016 Results of part 1 and part 2 of this study presented at the 52nd Annual Meeting of the European Association for the Study of Diabetes.