Trial Outcomes & Findings for Pharmacogenetics of Ace Inhibitor-Associated Angioedema (NCT NCT01413542)
NCT ID: NCT01413542
Last Updated: 2015-11-04
Results Overview
Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
44 participants
Primary outcome timeframe
60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehicle
Results posted on
2015-11-04
Participant Flow
44 participants were enrolled in this study (23 in Group 1 and 21 in Group 2) and completed screening procedures. Twelve of 23 participants met inclusion and exclusion criteria and completed all study-related procedures in Group 1. Seventeen of 21 participants met inclusion/exclusion criteria and completed all study-related procedures in Group 2.
Participant milestones
| Measure |
Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1
Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
|
Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1
Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
|
Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2
Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
|
Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2
Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
9
|
8
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
3
|
1
|
Reasons for withdrawal
| Measure |
Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1
Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
|
Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1
Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
|
Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2
Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
|
Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2
Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
|
|---|---|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
3
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Pharmacogenetics of Ace Inhibitor-Associated Angioedema
Baseline characteristics by cohort
| Measure |
Group 1
n=12 Participants
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
|
Group 2
n=17 Participants
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.1 years
STANDARD_DEVIATION 12.0 • n=39 Participants
|
35.4 years
STANDARD_DEVIATION 10.0 • n=41 Participants
|
36.5 years
STANDARD_DEVIATION 10.7 • n=35 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
14 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=39 Participants
|
17 participants
n=41 Participants
|
29 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 60 minutes post-placebo or sitagliptin (DPP4 inhibition) and over last 2 minutes of each 5 min infusion per peptide dose (30 min washout between peptides); sequence repeated with enalaprilat (ACE inhibition) or vehiclePopulation: In Group 1: Peptide 1=Max dose Bradykinin; Peptide 2=Substance P (SP) In Group 2: Peptide 1=GLP-1; Peptide 2=BNP (FBF expressed as percent change for both peptides) ACE inhibition=enalaprilat DPP4 inhibition=sitagliptin
Forearm blood flow (FBF) was measured by strain gauge plethysmography at the completion of each dose of intra-arterial peptide. A dose response curve was therefore constructed for each vasoactive peptide substrate. The effect of sitagliptin (DPP4 inhibition) vs. placebo and enalaprilat (ACE inhibition) vs. vehicle on the forearm blood flow response to each peptide could then be determined.
Outcome measures
| Measure |
Group 1
n=12 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
|
Group 2
n=17 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
|
|---|---|---|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect ACE inhibition on FBF response to Peptide 1
|
6.5 estimate of difference(ml/min/100ml FBF)
Interval 4.0 to 9.0
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 1 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4 inhibition on FBF Response to Peptide1
|
0.2 estimate of difference(ml/min/100ml FBF)
Interval -2.4 to 2.7
|
-5.0 estimate of difference(ml/min/100ml FBF)
Interval -11.6 to 1.6
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect ACE/DPP4 inhibit on FBF response Peptide 1
|
5.9 estimate of difference(ml/min/100ml FBF)
Interval 3.3 to 8.4
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 1 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4/ACEinhib vs. ACEinhib (FBF to Pep1)
|
-0.6 estimate of difference(ml/min/100ml FBF)
Interval -3.1 to 1.9
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 1 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4/ACEinhib vs. ACEinhib (FBF to Pep2)
|
-0.3 estimate of difference(ml/min/100ml FBF)
Interval -1.4 to 0.9
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 2 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4/ACEinhib vs. DPP4inhib (FBF to Pep1)
|
5.7 estimate of difference(ml/min/100ml FBF)
Interval 3.2 to 8.2
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 1 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect ACE inhibition on FBF response to Peptide 2
|
0.8 estimate of difference(ml/min/100ml FBF)
Interval -0.3 to 2.0
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 2 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4 inhibition on FBF response to Peptide2
|
0.1 estimate of difference(ml/min/100ml FBF)
Interval -0.1 to 1.3
|
-3.2 estimate of difference(ml/min/100ml FBF)
Interval -37.4 to 31.0
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect ACE/DPP4 inhibition on Peptide 2 FBF
|
0.6 estimate of difference(ml/min/100ml FBF)
Interval -0.6 to 1.7
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 2 is not a substrate of ace
|
|
The Effect of Enalaprilat (ACE Inhibition), Sitagliptin (DPP4 Inhibition), or the Combination on the Vasodilator Response (Forearm Blood Flow) to Substance P (SP) and Bradykinin (Group 1) or Glucagon Like Peptide-1 and Brain Naturetic Peptide (Group 2).
Effect DPP4/ACEinhib vs. DPP4inhib (FBF to Pep2)
|
0.4 estimate of difference(ml/min/100ml FBF)
Interval -0.8 to 1.6
|
NA estimate of difference(ml/min/100ml FBF)
effect of ace inhibition not studied in this group as peptide 2 is not a substrate of ace
|
SECONDARY outcome
Timeframe: Blood for analysis of tPA release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)Following measurement of FBF, samples will be obtained to determine the effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) (group 1)
Outcome measures
| Measure |
Group 1
n=5 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
|
Group 2
n=7 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
|
|---|---|---|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect ACE inhibition on bradykinin tPA release
|
118.6 estimate of difference (ng/min/100mL)
Interval 78.9 to 158.4
|
145.5 estimate of difference (ng/min/100mL)
Interval 107.0 to 184.1
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect of DPP4 inhibition on bradykinintPA release
|
1.6 estimate of difference (ng/min/100mL)
Interval -38.6 to 41.8
|
12.9 estimate of difference (ng/min/100mL)
Interval -26.5 to 52.3
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect of ACE/DPP4 inhibitio on bradykinin tPA
|
90.9 estimate of difference (ng/min/100mL)
Interval 50.8 to 131.0
|
132.1 estimate of difference (ng/min/100mL)
Interval 93.8 to 170.5
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
effect ace/dpp4 vs. aceinhibi on bradykinin tpa
|
-27.8 estimate of difference (ng/min/100mL)
Interval -68.2 to 12.6
|
-13.4 estimate of difference (ng/min/100mL)
Interval -52.1 to 25.3
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
effect ace/dpp4 vs. dpp4inhib on bradykinin tpa
|
89.3 estimate of difference (ng/min/100mL)
Interval 48.5 to 130.1
|
119.3 estimate of difference (ng/min/100mL)
Interval 80.2 to 158.3
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect of ACE inhibition on SP tPA release
|
-15.3 estimate of difference (ng/min/100mL)
Interval -41.8 to 11.3
|
43.9 estimate of difference (ng/min/100mL)
Interval 19.8 to 68.1
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect of DPP4 inhibition on SP tPA
|
-25.8 estimate of difference (ng/min/100mL)
Interval -52.4 to 0.8
|
-29.0 estimate of difference (ng/min/100mL)
Interval -53.4 to -4.6
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
Effect of ACE+DPP4 inhibition on SP tPA
|
0.8 estimate of difference (ng/min/100mL)
Interval -25.8 to 27.3
|
3.8 estimate of difference (ng/min/100mL)
Interval -20.5 to 28.2
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
effect ace/dpp4 vs. aceinhibi on SP tpa
|
16.1 estimate of difference (ng/min/100mL)
Interval -10.5 to 42.6
|
-40.1 estimate of difference (ng/min/100mL)
Interval -64.5 to -15.7
|
|
Assess Tissue Type Plasminogen Activator (tPA) Release
effect ace/dpp4 vs. dpp4inhibi on SP tpa
|
26.6 estimate of difference (ng/min/100mL)
Interval 0.0 to 53.1
|
32.8 estimate of difference (ng/min/100mL)
Interval 8.6 to 57.1
|
SECONDARY outcome
Timeframe: Heart rate was measured every 5 minutes throughout the study day (and thus during each dose of peptide infusion)Outcome measures
| Measure |
Group 1
n=12 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
|
Group 2
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
|
|---|---|---|
|
Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)
Change in Pulse after SP during Placebo
|
-1.8 beats per minute
Standard Error 1.76
|
—
|
|
Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)
Change in Pulse after SP w/ACE inhibition
|
2.55 beats per minute
Standard Error 1.04
|
—
|
|
Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)
Change in Pulse after SP w/DPP4inhibition
|
0.45 beats per minute
Standard Error 1.74
|
—
|
|
Assess Effect of ACE and/or DPP4 Inhibition on Heart Rate Response to Substance P (SP)
Pulse change after SP w/ACE+DPP4inhibition
|
4.55 beats per minute
Standard Error 1.87
|
—
|
SECONDARY outcome
Timeframe: Blood for analysis of norepinephrine (NE) release was obtained 60 minutes after sitagliptin (DPP4 inhibition) vs. placebo and after each assessment of FBF (see primary outcome measure)Outcome measures
| Measure |
Group 1
n=12 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
|
Group 2
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
|
|---|---|---|
|
Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)
Change NE AV Gradient with SP after placebo
|
-43.18 pg/mL
Standard Error 8.95
|
—
|
|
Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)
Change NE AV Gradient with SP after ACEinhibition
|
-52.18 pg/mL
Standard Error 18.34
|
—
|
|
Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)
Change NE AV Gradient with SP after DPP4inhibition
|
-37.27 pg/mL
Standard Error 12.21
|
—
|
|
Effect of Treatment (ACE or DPP4 Inhibition, or Combined) on Norepinephrine (NE) Release (Arterial Venous Gradient) in Response to Substance P (SP)
Change NE AV with SP after ACE+DPPinhibition
|
23.45 pg/mL
Standard Error 31.47
|
—
|
SECONDARY outcome
Timeframe: Blood for analysis of GLP-1 levels was obtained one hour after sitagliptin (DPP4 inhibition) vs. placebo administration and after each dose of GLP-1Outcome measures
| Measure |
Group 1
n=14 Participants
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
|
Group 2
Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
|
|---|---|---|
|
Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion
Venous GLP-1 levels 1 hour after placebo
|
5.13 pmol/L
Standard Error 1.05
|
—
|
|
Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion
Venous GLP-1 Levels after Max Dose GLP-1 (Placebo)
|
15.44 pmol/L
Standard Error 2.94
|
—
|
|
Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion
Venous GLP-1 levels 1 hour after DPP4 inhibition
|
5.39 pmol/L
Standard Error 0.99
|
—
|
|
Effect of Treatment (DPP4 Inhibition vs. Placebo) on Venous GLP-1 Levels in Response to Arterial GLP-1 Infusion
Venous GLP-1 levels Max Dose GLP-1 (DPP4inhibiton)
|
30.63 pmol/L
Standard Error 3.40
|
—
|
Adverse Events
Group 1 (Placebo Arm)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1 (Sitagliptin Arm)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2 (Placebo Arm)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 2 (Sitagliptin Arm)
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1 (Placebo Arm)
n=12 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
|
Group 1 (Sitagliptin Arm)
n=11 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
|
Group 2 (Placebo Arm)
n=16 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
|
Group 2 (Sitagliptin Arm)
n=14 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Orthostasis with Syncopal Event
|
0.00%
0/12
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/11
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/16
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
7.1%
1/14 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
Other adverse events
| Measure |
Group 1 (Placebo Arm)
n=12 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
|
Group 1 (Sitagliptin Arm)
n=11 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
|
Group 2 (Placebo Arm)
n=16 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
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Group 2 (Sitagliptin Arm)
n=14 participants at risk
Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Swelling of instrumented arm
|
0.00%
0/12
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
9.1%
1/11 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/16
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/14
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
|
Blood and lymphatic system disorders
Transient Lightheadedness
|
16.7%
2/12 • Number of events 2
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
9.1%
1/11 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
12.5%
2/16 • Number of events 2
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
7.1%
1/14 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
|
Renal and urinary disorders
Nephrolithiasis
|
8.3%
1/12 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/11
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/16
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/14
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
|
Nervous system disorders
Neuropraxia in the instrumented arm
|
0.00%
0/12
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/11
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
6.2%
1/16 • Number of events 1
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
|
0.00%
0/14
1 Subject (Group 1) did not complete sitagliptin arm due to inability to establish arterial access. 1 Subject (Group 2) did not complete placebo arm because the Investigator withdrew them after Serious Adverse Event. 3 Subjects (Group 2) did not complete the sitagliptin arm due to inability to establish arterial access during the sitagliptin arm.
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Additional Information
Dr. Nancy J. Brown
Department of Medicine Vanderbilt University Medical Center
Phone: 615-343-8701
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place