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

Trial Profile

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

Discontinued
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
  • Most Recent Events

    • 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.
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