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
  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:


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: July 2014
Estimated Primary Completion Date: July 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, Arkansas
Osborne Research Center Recruiting
Little Rock, Arkansas, United States, 72201
Contact: Robert E Harrell Jr, Site 0009    501-907-5003      
United States, California
Local Institution Not yet recruiting
Los Angeles, California, United States, 90036
Contact: Site 0008         
United States, Kentucky
Local Institution Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Site 0005         
United States, Missouri
Local Institution Not yet recruiting
Kansas City, Missouri, United States, 64108
Contact: Site 0003         
United States, New Jersey
Local Institution Not yet recruiting
Neptune, New Jersey, United States, 07753
Contact: Site 0011         
United States, Ohio
Local Institution Not yet recruiting
Toledo, Ohio, United States, 43606
Contact: Site 0002         
Local Institution Not yet recruiting
Toledo, Ohio, United States, 43606
Contact: Site 0001         
United States, Pennsylvania
Local Institution Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Site 0007         
Childrens Hospital Of Pittsburgh Of Upmc Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact: Christine Chan, Site 0006         
United States, Washington
Local Institution Not yet recruiting
Seattle, Washington, United States, 98105
Contact: Site 0010         
Sponsors and Collaborators
Bristol-Myers Squibb
AstraZeneca
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
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: July 26, 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 April 16, 2014