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Pharmacokinetics, Pharmacodynamics, and Safety of Alogliptin in Children, Adolescents and Adults With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00957268
First received: August 6, 2009
Last updated: January 26, 2015
Last verified: January 2015
Results First Received: November 21, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Condition: Diabetes Mellitus, Type 2
Intervention: Drug: Alogliptin

  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
Participants took part in the study at 6 investigative sites in the United States from 17 Sep 2009 to 22 Nov 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants aged 10 to 65 with a diagnosis of type 2 diabetes mellitus were enrolled in 1 of 5 treatment groups and received 12.5 or 25 mg alogliptin once.

Reporting Groups
  Description
Alogliptin 12.5 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 18 to 65 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.

Participant Flow:   Overall Study
    Alogliptin 12.5 mg (Age 10 to < 14 Years)     Alogliptin 25 mg (Age 10 to < 14 Years)     Alogliptin 12.5 mg (Age 14 to < 18 Years)     Alogliptin 25 mg (Age 14 to < 18 Years)     Alogliptin 25 mg (Age 18 to 65 Years)  
STARTED     5     4     8     7     22  
COMPLETED     5     4     7     7     22  
NOT COMPLETED     0     0     1     0     0  
Voluntary Withdrawal                 0                 0                 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.
Safety set: All enrolled participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Alogliptin 12.5 mg (Age 10 to < 14 Years) Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 10 to < 14 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 12.5 mg (Age 14 to < 18 Years) Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 14 to < 18 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Alogliptin 25 mg (Age 18 to 65 Years) Alogliptin 25 mg QD, tablets, orally, 1 dose only.
Total Total of all reporting groups

Baseline Measures
    Alogliptin 12.5 mg (Age 10 to < 14 Years)     Alogliptin 25 mg (Age 10 to < 14 Years)     Alogliptin 12.5 mg (Age 14 to < 18 Years)     Alogliptin 25 mg (Age 14 to < 18 Years)     Alogliptin 25 mg (Age 18 to 65 Years)     Total  
Number of Participants  
[units: participants]
  5     4     8     7     22     46  
Age  
[units: years]
Mean ± Standard Deviation
  12.4  ± 0.89     12.0  ± 0.82     15.4  ± 0.92     15.1  ± 0.69     51.3  ± 8.24     31.96  ± 19.67  
Gender  
[units: participants]
           
Female     4     3     6     5     16     34  
Male     1     1     2     2     6     12  
Race/Ethnicity, Customized  
[units: participants]
           
Hispanic or Latino     0     1     1     1     4     7  
Non-Hispanic or Latino     5     3     7     6     18     39  
Race/Ethnicity, Customized  
[units: participants]
           
Asian Black or African American     5     3     4     5     15     32  
White     0     1     4     2     7     14  
Height  
[units: cm]
Mean ± Standard Deviation
  162.4  ± 8.56     165.8  ± 8.88     168.6  ± 5.71     168.9  ± 9.03     167.5  ± 9.81     167.2  ± 8.73  
Weight  
[units: kg]
Mean ± Standard Deviation
  86.62  ± 13.979     98.90  ± 11.957     116.28  ± 33.163     103.71  ± 17.103     92.25  ± 16.454     97.14  ± 21.409  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation
  33.22  ± 4.621     36.16  ± 3.422     40.92  ± 9.190     36.46  ± 6.764     32.84  ± 4.490     35.01  ± 6.439  
Smoking Status  
[units: participants]
           
Never Smoked     5     4     8     7     14     38  
Current Smoker     0     0     0     0     0     0  
Ex-smoker     0     0     0     0     8     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Cmax: Maximum Observed Plasma Concentration for Alogliptin   [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

2.  Primary:   Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Alogliptin   [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

3.  Primary:   AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for Alogliptin   [ Time Frame: 1 hour pre-dose and 1, 2, 4, 8, 12, 16, 24, 48, and 72 hours post-dose ]

4.  Secondary:   Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

5.  Secondary:   Maximum Observed Effect (Emax) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

6.  Secondary:   Time to Reach the Maximum Observed Effect of Dipeptidyl Peptidase-4 (DPP-4) Inhibition   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

7.  Secondary:   Observed Effect at 24 Hours Post-dose (E24) of Dipeptidyl Peptidase-4 (DPP-4) Inhibition   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

8.  Secondary:   Area Under the Plasma Effect-Time Curve From Time 0 to 24 Hours Post-dose (AUEC[0-24]) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

9.  Secondary:   Maximum Observed Effect (Emax) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

10.  Secondary:   Time to Reach the Maximum Observed Effect of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]

11.  Secondary:   Observed Effect at 24 Hours Post-dose (E24) of the Baseline-corrected Glucagon-like Peptide-1 (GLP-1) Concentration   [ Time Frame: 1 hour pre-dose and 2, 4, 8, 12, and 24 hours post-dose ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com


No publications provided


Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00957268     History of Changes
Other Study ID Numbers: SYR-322_104, 2009-011221-13, U1111-1111-7810
Study First Received: August 6, 2009
Results First Received: November 21, 2014
Last Updated: January 26, 2015
Health Authority: United States: Food and Drug Administration