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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.
ClinicalTrials.gov Identifier: NCT00660075
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : December 11, 2012
Last Update Posted : December 11, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Location: CHUL Medical Centre Date: Fall 2007, Winter 2008, Fall 2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2-weeks run-in period. 6-weeks treatment with sitagliptin 100mg/d or placebo. 4-weeks washout period. 6-weeks treatment with sitagliptin or placebo.

Reporting Groups
  Description
Placebo First, Then Sitagliptin Participants were first administered placebo for 6 weeks followed by a washout period of 4 weeks and were then switched over to Sitagliptin 100 mg/d for 6 weeks.
Sitagliptin First, Then Placebo Participants were first administered Sitagliptin 100 mg/d for 6 weeks followed by a washout period of 4 weeks and were then switched over to placebo for 6 weeks.

Participant Flow for 3 periods

Period 1:   First Intervention (Week 1 to Week 6)
    Placebo First, Then Sitagliptin   Sitagliptin First, Then Placebo
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 

Period 2:   Washout Period (Week 7 to Week 10)
    Placebo First, Then Sitagliptin   Sitagliptin First, Then Placebo
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 

Period 3:   Second Intervention (Week 11 to Week 16
    Placebo First, Then Sitagliptin   Sitagliptin First, Then Placebo
STARTED   18   18 
COMPLETED   18   18 
NOT COMPLETED   0   0 



  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.
No text entered.

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 
Overall Participants Analyzed 
[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

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Sitagliptin Sitagliptin 100 mg/d for 6 weeks
Placebo Placebo for 6 weeks

Other Adverse Events
    Sitagliptin   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   0/18 (0.00%)   0/18 (0.00%) 



  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.


  More Information