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PK Study of Dapagliflozin in Pediatric Subjects With T2DM

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01525238
First received: January 31, 2012
Last updated: September 29, 2016
Last verified: September 2016
Results First Received: September 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Type 2 Diabetes Mellitus
Intervention: Drug: Dapagliflozin

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
53 participants enrolled; 24 randomized; 24 treated with study drug. 29 participants were not randomized due to no longer meeting study criteria (25), withdrawal of consent (2), or other reasons (2).

Reporting Groups
  Description
Dapagliflozin 2.5 mg Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
Dapagliflozin 5 mg Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
Dapagliflozin 10 mg Dapagliflozin: Tablet, Oral, 10 mg, Single-dose

Participant Flow:   Overall Study
    Dapagliflozin 2.5 mg   Dapagliflozin 5 mg   Dapagliflozin 10 mg
STARTED   8   8   8 
COMPLETED   7   8   8 
NOT COMPLETED   1   0   0 
Withdrawal by Subject                1                0                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 treated participants

Reporting Groups
  Description
Dapagliflozin 2.5 mg Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
Dapagliflozin 5 mg Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
Dapagliflozin 10 mg Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
Total Total of all reporting groups

Baseline Measures
   Dapagliflozin 2.5 mg   Dapagliflozin 5 mg   Dapagliflozin 10 mg   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   8   8   24 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.0  (1.69)   14.0  (2.39)   14.6  (2.13)   14.5  (2.04) 
Age, Customized 
[Units: Participants]
       
10 to <= 15 years   5   5   4   14 
16 to <= 17 years   3   3   4   10 
Gender 
[Units: Participants]
       
Female   5   5   5   15 
Male   3   3   3   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

2.  Primary:   Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

3.  Primary:   Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

4.  Primary:   Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

5.  Primary:   Mean Plasma Half-life (T-HALF) of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

6.  Primary:   Geometric Mean of Apparent Clearance After Extravascular Administration (CL/F) of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

7.  Primary:   Geometric Mean of Apparent Volume of Distribution at Terminal Phase After Extravascular Administration (Vz/F) of Dapagliflozin   [ Time Frame: Day 1 to Day 3 ]

8.  Secondary:   Geometric Mean of Maximum Observed Plasma Concentration (Cmax) of Dapagliflozin 3-O-Glucuronide   [ Time Frame: Day 1 to Day 3 ]

9.  Secondary:   Median Time of Maximum Observed Plasma Concentration (Tmax) of Dapagliflozin 3-O-Glucuronide   [ Time Frame: Day 1 to Day 3 ]

10.  Secondary:   Geometric Mean of Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of Dapagliflozin 3-O-Glucuronide   [ Time Frame: Day 1 to Day 3 ]

11.  Secondary:   Geometric Mean of Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] of Dapagliflozin 3-O-Glucuronide   [ Time Frame: Day 1 to Day 3 ]

12.  Secondary:   Mean Plasma Half-life (T-HALF) of Dapagliflozin 3-O-Glucuronide   [ Time Frame: Day 1 to Day 3 ]

13.  Secondary:   Mean Fasting Plasma Glucose Concentrations at Pre-dose on Day 1 and on Day 2 After an 8-hr Fasting   [ Time Frame: Day 1 (Pre-dose) to Day 2 ]

14.  Secondary:   Mean Change in Fasting Plasma Glucose From Baseline Until Day 2   [ Time Frame: Day 1 (Pre-dose) to Day 2 ]

15.  Secondary:   Mean Total Amount of Glucose Excreted in Urine Over 24 Hours   [ Time Frame: Time of dose to 24 hours post-dose, Day 1 to Day 2 ]

16.  Secondary:   Number of Participants With Vital Sign Abnormalities, Electrocardiogram (ECG) Abnormalities, or Physical Examination Abnormalities Following Study Drug Administration.   [ Time Frame: Day 1 to Day 3 ]

17.  Secondary:   Number of Participants With Marked Hematology Laboratory Abnormalities   [ Time Frame: Day 1 (Pre-dose) to Day 3 ]

18.  Secondary:   Number of Participants With Marked Serum Chemistry Abnormalities   [ Time Frame: Day 1 (Pre-dose) to Day 3 ]

19.  Secondary:   Number of Participants With Marked Abnormalities in Other Chemistry Testing   [ Time Frame: Day 1 (Pre-dose) to Day 3 ]

20.  Secondary:   Number of Participants With Marked Urinalysis Abnormalities   [ Time Frame: Day 1 (Pre-dose) to Day 3 ]


  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
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  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



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01525238     History of Changes
Other Study ID Numbers: MB102-091
2011-005225-40 ( EudraCT Number )
Study First Received: January 31, 2012
Results First Received: September 29, 2016
Last Updated: September 29, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board