A Study to Assess the Pharmacokinetics and the Ability for Pediatric Participants With Type 2 Diabetes to Swallow MK-0431A XR Tablets (MK-0431A-296)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01557504
First received: March 16, 2012
Last updated: May 6, 2015
Last verified: May 2015
Results First Received: April 6, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin/metformin XR
Drug: Placebo
Drug: Metformin
Drug: Thyroid hormone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sitagliptin/Metformin XR Followed by Placebo Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
Placebo Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.

Participant Flow:   Overall Study
    Sitagliptin/Metformin XR Followed by Placebo     Placebo  
STARTED     13     12  
COMPLETED     12     12  
NOT COMPLETED     1     0  
Physician Decision                 1                 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.
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Reporting Groups
  Description
Sitagliptin/Metformin XR Followed by Placebo Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
Placebo Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin/Metformin XR Followed by Placebo     Placebo     Total  
Number of Participants  
[units: participants]
  13     12     25  
Age, Customized  
[units: Participants]
     
10-13 years     4     3     7  
14-17 years     9     9     18  
Gender  
[units: Participants]
     
Female     9     8     17  
Male     4     4     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Who Successfully Swallowed Study Medication (Med) on Day 2   [ Time Frame: Day 2 ]

2.  Primary:   Number of Participants Who Successfully Swallowed Study Med on Day 4   [ Time Frame: Day 4 ]

3.  Primary:   Number of Participants Who Successfully Swallowed Study Med on Day 6   [ Time Frame: Day 6 ]

4.  Primary:   Number of Participants Who Successfully Swallowed Study Med on Day 9   [ Time Frame: Day 9 ]

5.  Primary:   Area Under the Curve 0 to Last (AUC 0-last) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

6.  Primary:   AUC 0-24 of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose ]

7.  Primary:   AUC 0-24 of Metformin Following Single Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, and 24 hours post-dose ]

8.  Primary:   Area Under the Curve 0 to Infinity (AUC 0-∞) of Sitagliptin Following Single Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

9.  Primary:   Cmax of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

10.  Primary:   Cmax of Metformin Following Single Dose Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

11.  Primary:   Tmax of Sitagliptin and Metformin Following Single Dose Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

12.  Primary:   Apparent Terminal Half Life (t1/2) of Sitagliptin Following Single Dose Administration of Sitagliptin/Metformin XR   [ Time Frame: Pre-dose, and 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, and 72 hours post-dose ]

13.  Primary:   Number of Participants Who Experienced an Adverse Event (AE)   [ Time Frame: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug) ]

14.  Primary:   Number of Participants Who Experienced an Abnormal Vital Sign Value   [ Time Frame: Up to 23 days (including approximately 10 to 14 days after the last dose of study drug) ]

15.  Primary:   Number of Participants Who Discontinued Study Drug Due to an AE   [ Time Frame: Up to 9 days ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01557504     History of Changes
Other Study ID Numbers: 0431A-296
Study First Received: March 16, 2012
Results First Received: April 6, 2015
Last Updated: May 6, 2015
Health Authority: United States: Food and Drug Administration