Sitagliptin and Kinetics of Triglyceride-rich Lipoproteins Apolipoprotein B48 and B100 in Patients With Type 2 Diabetes (JANUB48)

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Patrick Couture, Laval University
ClinicalTrials.gov Identifier:
NCT01334229
First received: April 11, 2011
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: July 22, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Sitagliptin Then Placebo First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
Placebo First Then Sitagliptin First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks

Participant Flow:   Overall Study
    Sitagliptin Then Placebo     Placebo First Then Sitagliptin  
STARTED     11     11  
COMPLETED     11     11  
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.
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Reporting Groups
  Description
Sitagliptin First Then Placebo First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
Placebo First Then Sitagliptin First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
Total Total of all reporting groups

Baseline Measures
    Sitagliptin First Then Placebo     Placebo First Then Sitagliptin     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  57.5  ± 4.6     59  ± 2.9     58.2  ± 3.8  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     11     11     22  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     2     2     4  
Male     9     9     18  
Region of Enrollment  
[units: participants]
     
Canada     11     11     22  



  Outcome Measures
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1.  Primary:   Measurement of Apolipoprotein B48 and Apolipoprotein B100 Production Rates With Stable Isotope During Postprandial Period   [ Time Frame: 6 weeks ]

2.  Secondary:   Measurement of Glucagon-like Peptide-1 by ELISA   [ Time Frame: 6 weeks ]

3.  Secondary:   Measurement of Glucose   [ Time Frame: 6 weeks ]

4.  Secondary:   Measurement of Insulin   [ Time Frame: 6 weeks ]

5.  Secondary:   Measurement of Apolipoprotein B48 and Apolipoprotein B100 Pool Sizes With Stable Isotope During Postprandial Period   [ Time Frame: 6 weeks ]

6.  Secondary:   Measurement of Apolipoprotein B48 and Apolipoprotein B100 Fractional Catabolic Rates With Stable Isotope During Postprandial Period   [ Time Frame: 6 weeks ]


  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 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: Dr. Patrick Couture MD, PhD, FRCP
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: NCT01334229     History of Changes
Other Study ID Numbers: IIS#39262
Study First Received: April 11, 2011
Results First Received: July 22, 2014
Last Updated: September 3, 2014
Health Authority: Canada: Health Canada