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

This study has been terminated.
(Release of Post Marketing Requirement for this study. Terminated November 2013.)
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525225
First received: January 31, 2012
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: August 11, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Metformin immediate release (IR)
Drug: Saxagliptin
Drug: Metformin IR
Drug: Saxagliptin/Metformin XR FDC
Drug: Metformin XR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Upon approval of Kombiglyze™ XR, the Food and Drug Administration (FDA) required the conduct of this clinical pharmacology study in pediatric patients as a post-marketing requirement (PMR). Study was initiated February 2013. On 14-Nov-13, the FDA issued a letter stating release from this PMR, thus the study was terminated prior to completion.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 4 participants were enrolled. Two participants were treated and completed the study prior to the termination of the study.

Reporting Groups
  Description
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.

Participant Flow for 2 periods

Period 1:   Enrollment
    Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC  
STARTED     4  
COMPLETED     2  
NOT COMPLETED     2  
No longer met study criteria                 1  
Not Specified                 1  

Period 2:   Treated
    Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All participants who received at least one dose of study drug.

Reporting Groups
  Description
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.

Baseline Measures
    Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC  
Number of Participants  
[units: participants]
  2  
Age  
[units: years]
Median ( Full Range )
  13.0  
  ( 10.0 to 16.0 )  
Gender  
[units: participants]
 
Female     2  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
Black/African American     1  
White     1  
Region of Enrollment  
[units: participants]
 
United States     2  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death   [ Time Frame: Day 1 up to Day 8, plus 30 days ]

2.  Secondary:   Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities   [ Time Frame: Day 1 to Day 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Due to the small number of participants (2), the primary endpoints, pharmacokinetic parameters, were not calculated.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com


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
Results First Received: August 11, 2014
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board