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 6, 2014
Last verified: August 2014
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 ]
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Measure Type Secondary
Measure Title Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin
Measure Description Serum samples were used to determine the Tmax 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  
Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin  
[units: hours]
Median ( Full Range )
  3.0  
  ( 1.5 to 5.0 )  
  3.0  
  ( 2.0 to 4.5 )  
  2.5  
  ( 1.0 to 3.1 )  

No statistical analysis provided for Time of Occurence of Maximum Concentration (Tmax) Following a Single Dose of Sitagliptin



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

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


  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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