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Sitagliptin Therapy and Kinetics of Inflammatory Markers

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ClinicalTrials.gov Identifier: NCT02536248
Recruitment Status : Completed
First Posted : August 31, 2015
Results First Posted : May 13, 2020
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
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
Condition Type 2 Diabetes Mellitus
Interventions Drug: Sitagliptin
Drug: Placebo
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sitagliptin First Then Placebo Placebo First, Then Sitagliptin
Hide Arm/Group Description

Sitagliptin 100 mg/d for 6 weeks

Wash-out 14 days

Placebo for 6 weeks

Placebo for 6 weeks

Wash-out 14 days

Sitagliptin 100 mg/d for 6 weeks

Period Title: First Intervention (6 Weeks)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Wash-out (14 Days)
Started 10 10
Completed 10 10
Not Completed 0 0
Period Title: Second Intervention (6 Weeks)
Started 10 10
Completed 10 10
Not Completed 0 0
Arm/Group Title Sitagliptin First Then Placebo Placebo First Then Sitagliptin Total
Hide Arm/Group Description

Sitagliptin 100 mg/d for 6 weeks

Sitagliptin: Sitagliptin 100 mg/d for 6 weeks

Placebo for 6 weeks

Placebo: Placebo for 6 weeks

Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
10
 100.0%
20
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
58.0  (4.6) 58.5  (3.2) 58.3  (3.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
2
  20.0%
2
  20.0%
4
  20.0%
Male
8
  80.0%
8
  80.0%
16
  80.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Measurement of C-reactive Protein Production Rate With Stable Isotope During Postprandial Period
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (C-reactive protein).
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg/d for 6 weeks
Placebo for 6 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Measurement of Serum Amyloid A Production Rate With Stable Isotope During Postprandial Period
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg/d for 6 weeks
Placebo for 6 weeks
Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: mg/kg/day
0.039  (0.030) 0.049  (0.047)
3.Secondary Outcome
Title Measurement of L-selectin Production Rate With Stable Isotope During Postprandial Period
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (L-selectin).
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg/d for 6 weeks
Placebo for 6 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Measurement of ICAM-1 Production Rate With Stable Isotope During Postprandial Period
Hide Description [Not Specified]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (I-CAM-1).
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description:
Sitagliptin 100 mg/d for 6 weeks
Placebo for 6 weeks
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame During 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sitagliptin Placebo
Hide Arm/Group Description

Sitagliptin 100 mg/d for 6 weeks

Sitagliptin: Sitagliptin 100 mg/d for 6 weeks

Placebo for 6 weeks

Placebo: Placebo for 6 weeks

All-Cause Mortality
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Serious Adverse Events
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sitagliptin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
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
Layout table for Results Point of Contact information
Name/Title: Dr. Patrick Couture MD, PhD, FRCP
Organization: Laval university
Phone: 418-654-2106
EMail: patrick.couture@crchul.ulaval.ca
Layout table for additonal information
Responsible Party: Patrick Couture, Laval University
ClinicalTrials.gov Identifier: NCT02536248    
Other Study ID Numbers: JANU-INF
First Submitted: August 27, 2015
First Posted: August 31, 2015
Results First Submitted: March 30, 2020
Results First Posted: May 13, 2020
Last Update Posted: May 13, 2020