Trial Outcomes & Findings for Sitagliptin Therapy and Kinetics of Inflammatory Markers (NCT NCT02536248)
NCT ID: NCT02536248
Last Updated: 2020-05-13
Results Overview
COMPLETED
PHASE3
20 participants
6 weeks
2020-05-13
Participant Flow
Participant milestones
| Measure |
Sitagliptin First Then Placebo
Sitagliptin 100 mg/d for 6 weeks
Wash-out 14 days
Placebo for 6 weeks
|
Placebo First, Then Sitagliptin
Placebo for 6 weeks
Wash-out 14 days
Sitagliptin 100 mg/d for 6 weeks
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
10
|
10
|
|
First Intervention (6 Weeks)
COMPLETED
|
10
|
10
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
|
Wash-out (14 Days)
STARTED
|
10
|
10
|
|
Wash-out (14 Days)
COMPLETED
|
10
|
10
|
|
Wash-out (14 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
10
|
10
|
|
Second Intervention (6 Weeks)
COMPLETED
|
10
|
10
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sitagliptin First Then Placebo
n=10 Participants
Sitagliptin 100 mg/d for 6 weeks
Sitagliptin: Sitagliptin 100 mg/d for 6 weeks
|
Placebo First Then Sitagliptin
n=10 Participants
Placebo for 6 weeks
Placebo: Placebo for 6 weeks
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 4.6 • n=10 Participants
|
58.5 years
STANDARD_DEVIATION 3.2 • n=10 Participants
|
58.3 years
STANDARD_DEVIATION 3.8 • n=20 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=10 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=10 Participants
|
8 Participants
n=10 Participants
|
16 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
10 participants
n=10 Participants
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (C-reactive protein).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksOutcome measures
| Measure |
Sitagliptin
n=20 Participants
Sitagliptin 100 mg/d for 6 weeks
|
Placebo
n=20 Participants
Placebo for 6 weeks
|
|---|---|---|
|
Measurement of Serum Amyloid A Production Rate With Stable Isotope During Postprandial Period
|
0.039 mg/kg/day
Standard Deviation 0.030
|
0.049 mg/kg/day
Standard Deviation 0.047
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (L-selectin).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 weeksPopulation: Results for this outcome are not available since we had issues with the measurement of deuterated leucine in the current protein (I-CAM-1).
Outcome measures
Outcome data not reported
Adverse Events
Sitagliptin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place