Trial Outcomes & Findings for Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes (NCT NCT00660075)
NCT ID: NCT00660075
Last Updated: 2012-12-11
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
At the end of the two 6-week interventions
Results posted on
2012-12-11
Participant Flow
Location: CHUL Medical Centre Date: Fall 2007, Winter 2008, Fall 2008
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.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
First Intervention (Week 1 to Week 6)
STARTED
|
18
|
18
|
|
First Intervention (Week 1 to Week 6)
COMPLETED
|
18
|
18
|
|
First Intervention (Week 1 to Week 6)
NOT COMPLETED
|
0
|
0
|
|
Washout Period (Week 7 to Week 10)
STARTED
|
18
|
18
|
|
Washout Period (Week 7 to Week 10)
COMPLETED
|
18
|
18
|
|
Washout Period (Week 7 to Week 10)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Week 11 to Week 16
STARTED
|
18
|
18
|
|
Second Intervention (Week 11 to Week 16
COMPLETED
|
18
|
18
|
|
Second Intervention (Week 11 to Week 16
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Sitagliptin
n=18 Participants
Sitagliptin 100 mg/d for 6 weeks
|
Placebo
n=18 Participants
Placebo for 6 weeks
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
57.4 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
58.8 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
58.1 years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the end of the two 6-week interventionsPopulation: We analyzed all the subjects involved in the study. The analysis was per protocol. We compared data from the placebo phase with the sitagliptin phase.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo for 6 weeks
|
Sitagliptin 100 mg/d
n=36 Participants
Sitagliptin 100 mg/d for 6 weeks
|
|---|---|---|
|
Measurement of the Area Under the Curve of Plasma Triglycerides (TG) Levels During Postprandial Period (Time 0,2,4,6,8 Hours)
|
30.0 mmol*h/L
Standard Deviation 14.5
|
27.1 mmol*h/L
Standard Deviation 13.0
|
Adverse Events
Sitagliptin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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