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
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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
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
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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
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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Patrick Couture
Organization: Laval University
phone: 418-654-2106
e-mail: patrick.couture@crchul.ulaval.ca


No publications provided


Responsible Party: Patrick Couture, Laval University
ClinicalTrials.gov Identifier: NCT00660075     History of Changes
Other Study ID Numbers: SITA001
Study First Received: April 14, 2008
Results First Received: May 18, 2011
Last Updated: November 13, 2012
Health Authority: Canada: Health Canada