Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM

This study is currently recruiting participants.
Verified July 2013 by Bristol-Myers Squibb
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525225
First received: January 31, 2012
Last updated: July 26, 2013
Last verified: July 2013

January 31, 2012
July 26, 2013
February 2013
July 2014   (final data collection date for primary outcome measure)
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Days 1, 2, 7 and 8 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of 5-hydroxy Saxagliptin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration (Cmax) of Metformin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 24 hours [AUC(0-24)] of Metformin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to 12 hours [AUC(0-12)] of Metformin [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01525225 on ClinicalTrials.gov Archive Site
  • Safety: based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests [ Time Frame: Up to 8 days ] [ Designated as safety issue: Yes ]
  • Formulation swallowability of Saxagliptin-Metformin FDC tablet, Glucophage® IR tablet and Glucophage® XR tablet [ Time Frame: Days 1, Days 7, and Days 8 ] [ Designated as safety issue: No ]
    Formulation Swallowability: Subjects will respond to a questionnaire regarding their experience swallowing Saxagliptin-Metformin fixed dose combination (FDC) tablet, Glucophage® immediate release (IR) tablet and Glucophage® extended release (XR) tablet. The question regarding ease of swallowability will consist of the following categories for a response: easy, acceptable, difficult, and unable to swallow
Same as current
Not Provided
Not Provided
 
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
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

The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM)

The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Type 2 Diabetes Mellitus
  • Drug: Metformin IR
    Tablet, Oral, 1000 mg, twice daily, 1 day
    Other Name: Glucophage® IR
  • Drug: Saxagliptin
    Tablet, Oral, 5 mg, single-dose, 1 day
  • Drug: Metformin IR
    Tablet, Oral, 1000 mg, twice daily, 5 days
    Other Name: Glucophage® IR
  • Drug: Saxagliptin/Metformin XR FDC
    Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin XR, Single-dose of 2 tablets
  • Drug: Metformin XR
    Tablet, Oral, 500 mg, Single-dose of 4 tablets
    Other Name: Glucophage® XR
Experimental: Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
Interventions:
  • Drug: Metformin IR
  • Drug: Saxagliptin
  • Drug: Metformin IR
  • Drug: Saxagliptin/Metformin XR FDC
  • Drug: Metformin XR
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
July 2014
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of T2DM
  • Male and female subjects ages 10-17
  • Body weight ≥50 kg
  • Glycosylated hemoglobin (HbA1c) 6.5 to 10%

Exclusion Criteria:

  • Fasting plasma glucose (FPG) > 240 mg/dL at screening
  • Abnormal renal function
  • Active liver disease and/or significant abnormal liver function
Both
10 Years to 17 Years
No
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
United States
 
NCT01525225
CV181-153
No
Bristol-Myers Squibb
Bristol-Myers Squibb
AstraZeneca
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP