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

This study is not yet open for participant recruitment.
Verified April 2012 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: February 7, 2013
Last verified: April 2012
History of Changes
  Purpose

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)


Condition Intervention Phase
Type 2 Diabetes Mellitus
 Drug: Metformin IR
Drug: Saxagliptin
Drug: Saxagliptin/Metformin XR FDC
Drug: Metformin XR
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 12
Study Start Date: February 2013
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC 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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   10 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01525225

Contacts
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.

Locations
United States, Texas
University Of Texas Health Science Center At San Antonio Terminated
San Antonio, Texas, United States, 78284
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trial Information  This link exits the ClinicalTrials.gov site
BMS clinical trial educational resource  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01525225     History of Changes
Other Study ID Numbers: CV181-153
Study First Received: January 31, 2012
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Saxagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013