Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage (Metformin) IR Tablets
Phase of Trial: Phase I
Latest Information Update: 30 Jun 2015
At a glance
- Drugs Saxagliptin/metformin (Primary) ; Metformin; Saxagliptin
- Indications Type 2 diabetes mellitus
- Focus Adverse reactions
- Sponsors Bristol-Myers Squibb
- 25 Aug 2014 Primary endpoint was amended from phamacokinetic parameters to adverse reactions and hence, trial focus has also been changed accordingly.
- 12 Jun 2014 Status changed from recruiting to discontinued as reported by ClinicalTrials.gov record.
- 26 Jul 2013 Planned End Date changed from 1 Jan 2014 to 1 Jul 2014 as reported by ClinicalTrials.gov.