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A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00830076
First received: January 26, 2009
Last updated: August 5, 2014
Last verified: August 2014
Results First Received: September 29, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: sitagliptin phosphate
Drug: metformin hydrochloride
Drug: Comparator: placebo sitagliptin
Drug: Comparator: placebo metformin

  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
All Participants Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.

Participant Flow for 7 periods

Period 1:   Sitagliptin + Placebo Metformin
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 2:   7-day Washout
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 3:   Metformin + Placebo Sitagliptin
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 4:   7-day Washout
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 5:   Sitagliptin + Metformin
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 6:   7-day Washout
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     0  

Period 7:   Placebo Sitagliptin + Placebo Metformin
    All Participants  
STARTED     18  
COMPLETED     18  
NOT COMPLETED     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.
No text entered.

Reporting Groups
  Description
All Participants Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  18  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     17  
>=65 years     1  
Gender  
[units: participants]
 
Female     5  
Male     13  
Region of Enrollment  
[units: participants]
 
United States     18  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Incremental Post-prandial 4-hour Weighted Mean Active Glucagon-like Peptide-1 (GLP-1) Plasma Concentrations   [ Time Frame: 6 hours postdose (4 hours postmeal) on Day 2 ]

2.  Secondary:   β-cell Sensitivity   [ Time Frame: 6 hour post-dose (4 hour postmeal) on Day 2 ]

3.  Secondary:   Incremental Post-prandial 4-hour Weighted Mean Plasma Glucose Concentrations   [ Time Frame: 6 hours postdose (4 hours postmeal) on Day 2 ]


  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: Vice President, Late Stage Development Group Leader
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: NCT00830076     History of Changes
Other Study ID Numbers: 0431-110, 2009_521
Study First Received: January 26, 2009
Results First Received: September 29, 2011
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration