A Study to Assess the Pharmacokinetics, Safety and Tolerability of Sitagliptin in Adolescents (0431-081)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00730275
First received: August 6, 2008
Last updated: August 29, 2013
Last verified: August 2013
Results First Received: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Sitagliptin phosphate
Drug: Comparator: matching placebo

  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
No text entered.

Reporting Groups
  Description
Sitagliptin 50 mg Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg Participants who received a single oral dose of sitagliptin 200 mg.
Placebo Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.

Participant Flow:   Overall Study
    Sitagliptin 50 mg     Sitagliptin 100 mg     Sitagliptin 200 mg     Placebo  
STARTED     9     9     8     9  
COMPLETED     9     9     8     8  
NOT COMPLETED     0     0     0     1  
Withdrawal by Subject                 0                 0                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Sitagliptin 50 mg Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg Participants who received a single oral dose of sitagliptin 200 mg.
Placebo Participants who received a single oral dose of a matching placebo to sitagliptin 50 mg, 100 mg, or 200 mg.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 50 mg     Sitagliptin 100 mg     Sitagliptin 200 mg     Placebo     Total  
Number of Participants  
[units: participants]
  9     9     8     9     35  
Age  
[units: years]
Mean ± Standard Deviation
  13.9  ± 2.52     14.3  ± 1.41     14.8  ± 1.75     14.1  ± 2.26     14.3  ± 1.98  
Gender  
[units: participants]
         
Female     6     5     5     8     24  
Male     3     4     3     1     11  



  Outcome Measures
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1.  Primary:   Number of Participants Who Experienced at Least One Adverse Event   [ Time Frame: Pre-study through 10 to 14 days following administration of study drug ]

2.  Primary:   Area Under the Concentration-time Curve (AUC) From Time 0 to Infinity Following a Single Dose of Sitagliptin   [ Time Frame: Pre-dose through 72 hours post-dose ]

3.  Secondary:   Maximum Concentration (Cmax) Following a Single Dose of Sitagliptin   [ Time Frame: Pre-dose through 72 hours post-dose ]

4.  Secondary:   Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin   [ Time Frame: Pre-dose through 72 hours post-dose ]

5.  Secondary:   Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin   [ Time Frame: Pre-dose through 72 hours post-dose ]
  Hide Outcome Measure 5

Measure Type Secondary
Measure Title Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin
Measure Description Serum samples were used to determine the apparent t1/2 for sitagliptin. The placebo group is not included in the table below; this outcome measure only evaluated the sitagliptin groups.
Time Frame Pre-dose through 72 hours post-dose  
Safety Issue No  

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 a single dose of sitagliptin 50 mg, 100 mg, or 200 mg.

Reporting Groups
  Description
Sitagliptin 50 mg Participants who received a single oral dose of sitagliptin 50 mg.
Sitagliptin 100 mg Participants who received a single oral dose of sitagliptin 100 mg.
Sitagliptin 200 mg Participants who received a single oral dose of sitagliptin 200 mg.

Measured Values
    Sitagliptin 50 mg     Sitagliptin 100 mg     Sitagliptin 200 mg  
Number of Participants Analyzed  
[units: participants]
  9     9     8  
Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin  
[units: hours]
Mean ± Standard Deviation
  12.1  ± 1.7     11.2  ± 2.1     11.7  ± 1.8  

No statistical analysis provided for Apparent Terminal Half-life (Apparent t1/2) Following a Single Dose of Sitagliptin



6.  Secondary:   Plasma Dipeptidyl Peptidase-4 (DPP-4) Activity Following a Single Dose of Sitagliptin or Placebo   [ Time Frame: Pre-dose through 24 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President, Late Stage Development Group Leader
Organization: Merck Sharpe & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00730275     History of Changes
Other Study ID Numbers: 0431-081, 2008_540
Study First Received: August 6, 2008
Results First Received: December 21, 2011
Last Updated: August 29, 2013
Health Authority: United States: Food and Drug Administration