Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patrick Couture, Laval University
ClinicalTrials.gov Identifier:
NCT00660075
First received: April 14, 2008
Last updated: November 13, 2012
Last verified: November 2012
Results First Received: May 18, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Postprandial Lipemia
Interventions: Drug: Sitagliptin
Drug: Placebo

  Participant Flow


  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 Sitagliptin 100 mg/d for 6 weeks
Placebo Placebo for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Placebo     Total  
Number of Participants  
[units: participants]
  18     18     36  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     2     2     4  
Age  
[units: years]
Mean ± Standard Deviation
  57.4  ± 6.5     58.8  ± 6.3     58.1  ± 6.4  
Gender  
[units: participants]
     
Female     0     6     6  
Male     18     12     30  
Region of Enrollment  
[units: participants]
     
Canada     18     18     36  



  Outcome Measures

1.  Primary:   Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)   [ Time Frame: At the end of the two 6-week interventions ]


  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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