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

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. Identifier: NCT00660075
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patrick Couture, Laval University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Postprandial Lipemia
Interventions: Drug: Sitagliptin
Drug: Placebo

  Participant Flow

  Baseline Characteristics

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

Baseline Measures
   Sitagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 18   18   36 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   16   16   32 
>=65 years   2   2   4 
[Units: Years]
Mean (Standard Deviation)
 57.4  (6.5)   58.8  (6.3)   58.1  (6.4) 
[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

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