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Bioequivalence Study of Sitagliptin/Metformin Combination Tablet (MK0431A-122)

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01093794
First received: March 19, 2010
Last updated: June 3, 2011
Last verified: June 2011
History of Changes
Results First Received: June 3, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Bio-equivalence Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Type 2 Diabetes
Interventions: Drug: Co-administration of 50 mg sitagliptin and 500 mg metformin
Drug: sitagliptin/metformin 50 mg/500 mg tablet
Drug: Co-administration of 50 mg sitagliptin and 850 mg metformin
Drug: sitagliptin/metformin 50 mg/850 mg tablet

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
28 participants were randomized in four treatment sequences. Participants had a 7 day minimum washout period between treatments.

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
1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • Co-administration of 50 mg sitagliptin and 500 mg metformin
  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 850 mg metformin
2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • Co-administration of 50 mg sitagliptin and 500mg metformin
  • sitagliptin/metformin 50 mg/850 mg FDC tablet
3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • sitagliptin/metformin 50 mg/500 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 500mg metformin
4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC

Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:

  • sitagliptin/metformin 50 mg/850 mg FDC tablet
  • Co-administration of 50 mg sitagliptin and 500 mg metformin
  • Co-administration of 50 mg sitagliptin and 850 mg metformin
  • sitagliptin/metformin 50 mg/500 mg FDC tablet

Participant Flow for 4 periods

 Period 1:   Treatment Period 1
    1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850     2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC     3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500     4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC  
STARTED     7     7     7     7  
COMPLETED     7     7     7     7  
NOT COMPLETED     0     0     0     0  

Period 2:   Treatment Period 2
    1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850     2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC     3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500     4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC  
STARTED     7     7     6 [1]   7  
COMPLETED     7     7     6     7  
NOT COMPLETED     0     0     0     0  
[1] After period 1, one participant was discontinued by the investigator due to a protocol deviation.

Period 3:   Treatment Period 3
    1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850     2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC     3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500     4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC  
STARTED     7     7     6     7  
COMPLETED     7     7     6     7  
NOT COMPLETED     0     0     0     0  

Period 4:   Treatment Period 4
    1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850     2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC     3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500     4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC  
STARTED     7     7     6     7  
COMPLETED     7     7     6     7  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
All Participants No text entered.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
 		  28  
Age  
[units: years]
Mean ± Standard Deviation 		  28.6  ± 5.61  
Gender  
[units: participants]
 		 
Female     0  
Male     28  
Region of Enrollment  
[units: participants]
 		 
China     28  
Body Mass Index (BMI)  
[units: kg/m^2]
Mean ± Standard Deviation 		  22  ± 1.22  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Curve (AUC(0-t)) for Sitagliptin   [ Time Frame: baseline through 72 hours postdose ]
  Show Outcome Measure 1

2.  Primary:   Cmax for Sitagliptin and Metformin   [ Time Frame: baseline through 72 hours postdose ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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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.


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 Sharp & Dohme
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01093794     History of Changes
Other Study ID Numbers: MK-0431A-122, 2010_518
Study First Received: March 19, 2010
Results First Received: June 3, 2011
Last Updated: June 3, 2011
Health Authority: China: Ministry of Health