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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00730275
First Posted: August 8, 2008
Last Update Posted: May 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: December 21, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Overall Participants Analyzed 
[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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      6  66.7%      5  55.6%      5  62.5%      8  88.9%      24  68.6% 
Male      3  33.3%      4  44.4%      3  37.5%      1  11.1%      11  31.4% 


  Outcome Measures
  Show All Outcome Measures

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  

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 
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


  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