Trial Outcomes & Findings for Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome (NCT NCT00666848)
NCT ID: NCT00666848
Last Updated: 2012-05-11
Results Overview
The change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
just prior to drug administration and 8 hours after drug administration
Results posted on
2012-05-11
Participant Flow
Subjects received a placebo pill for 5 days prior then arm 1,2,or3 and crossed over to sitagliptin 100mg/day for 5 days prior to arm 1,2,or3. This is a parallel cross over study. 43 subjects were consented. 15 did not meet inclusion criteria. 3 withdrew before randomization.
Participant milestones
| Measure |
2 (Enalapril 5mg)
Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
|
1 (Placebo)
Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
|
3 (Enalapril 10mg)
Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
7
|
|
Overall Study
COMPLETED
|
8
|
9
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Sitagliptin and an ACE Inhibitor on Blood Pressure in Metabolic Syndrome
Baseline characteristics by cohort
| Measure |
2 (Enalapril 5mg)
n=8 Participants
Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
|
1 (Placebo)
n=9 Participants
Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
|
3 (Enalapril 10mg)
n=7 Participants
Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
|
Total
n=24 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
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age Continuous
|
42 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
44 years
STANDARD_DEVIATION 13.9 • n=7 Participants
|
41 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
43 years
STANDARD_DEVIATION 2.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
9 participants
n=7 Participants
|
7 participants
n=5 Participants
|
24 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: just prior to drug administration and 8 hours after drug administrationThe change in mean arterial pressure (MAP) in response to placebo or enalapril after pretreatment with 5 days of placebo
Outcome measures
| Measure |
2 (Enalapril 5mg)
n=8 Participants
Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
|
1 (Placebo)
n=9 Participants
Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
|
3 (Enalapril 10mg)
n=7 Participants
Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
|
|---|---|---|---|
|
Change in MAP During Placebo
|
-0.9 mmHg
Standard Deviation 2.5
|
2.7 mmHg
Standard Deviation 2.1
|
-7.9 mmHg
Standard Deviation 2.4
|
PRIMARY outcome
Timeframe: just prior to drug administration and 8 hours following treatmentMean change in mean arterial pressure in response to placebo or enalapril in the presence of 5 days of sitagliptin 100mg/day
Outcome measures
| Measure |
2 (Enalapril 5mg)
n=8 Participants
Subjects received Enalapril 5mg on study day and a placebo pill for 5 days prior or subjects received enalapril 5mg on study day and sitagliptin 100mg/day for 5 days prior .
|
1 (Placebo)
n=9 Participants
Subjects received a placebo pill on study day and received a placebo pill for 5 days prior or subjects received a Placebo pill on study day and sitagliptin 100mg for 5 days prior.
|
3 (Enalapril 10mg)
n=7 Participants
Subjects received Enalapril 10mg on study day and a placebo pill for 5 days prior, or subjects received Enalapril 10mg on study day and sitagliptin 100mg for 5 days prior.
|
|---|---|---|---|
|
Change in MAP During Sitagliptin
|
-5.7 mmHg
Standard Deviation 2.0
|
-2.3 mmHg
Standard Deviation 2.0
|
-0.9 mmHg
Standard Deviation 2.3
|
Adverse Events
2 (Enalapril 5mg)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1 (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
3 (Enalapril 10mg)
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
Nancy J. Brown, M.D.
Vanderbilt University School of Medicine
Phone: 615-343-8701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place