Trial Outcomes & Findings for Effect of DPP4 Inhibition on Growth Hormone Secretion (NCT NCT01701973)
NCT ID: NCT01701973
Last Updated: 2018-05-29
Results Overview
Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
44 participants
Primary outcome timeframe
Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes
Results posted on
2018-05-29
Participant Flow
Healthy Lean Adults are randomized to two cross-over studies (Aim 1 and Aim 2).
In Aim 1, Healthy adults were randomized in a double-blinded cross-over fashion to sitagliptin vs placebo. A minimum 8 week wash-out separated Aims 1 \& 2. 23 of the same adults who completed Aim 1 participated in Aim 2. In Aim 2, these adults were divided into three subgroups and randomized to sitagliptin+placebo vs. sitagliptin+antagonist.
Participant milestones
| Measure |
Aim 1: Sitagliptin, Then Placebo
In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
|
Aim 1: Placebo, Then Sitagliptin
In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
|
Aim 2: Sitagliptin + Placebo,Then Sitagliptin + LNMMA
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
|
Aim 2:Sitagliptin + LNMMA, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
|
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Pegvisomant
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
|
Aim 2: Sitagliptin + Pegvisomant, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
|
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Exendin 9-39
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
|
Aim 2: Sitagliptin + Exendin 9-39, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Aim 1: First Intervention (1 Day)
STARTED
|
23
|
21
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 1: First Intervention (1 Day)
COMPLETED
|
23
|
20
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 1: First Intervention (1 Day)
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 1: Second Intervention (1 Day)
STARTED
|
22
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 1: Second Intervention (1 Day)
COMPLETED
|
22
|
17
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 1: Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 2: First Intervention (1 Day)
STARTED
|
0
|
0
|
5
|
4
|
2
|
3
|
5
|
4
|
|
Aim 2: First Intervention (1 Day)
COMPLETED
|
0
|
0
|
5
|
4
|
2
|
3
|
5
|
4
|
|
Aim 2: First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Aim 2: Second Intervention (1 Day)
STARTED
|
0
|
0
|
5
|
4
|
2
|
3
|
5
|
3
|
|
Aim 2: Second Intervention (1 Day)
COMPLETED
|
0
|
0
|
5
|
4
|
2
|
3
|
5
|
3
|
|
Aim 2: Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Aim 1: Sitagliptin, Then Placebo
In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
|
Aim 1: Placebo, Then Sitagliptin
In Aim 1: Healthy Lean adults are randomized in a double-blinded cross over fashion to sitagliptin versus placebo.
|
Aim 2: Sitagliptin + Placebo,Then Sitagliptin + LNMMA
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
|
Aim 2:Sitagliptin + LNMMA, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either L-NMMA (L-N-Monomethyl-arginine) versus placebo.
|
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Pegvisomant
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
|
Aim 2: Sitagliptin + Pegvisomant, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either pegvisomant versus placebo.
|
Aim 2: Sitagliptin + Placebo, Then Sitagliptin + Exendin 9-39
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
|
Aim 2: Sitagliptin + Exendin 9-39, Then Sitagliptin + Placebo
In Aim 2: Healthy Lean adults receive sitagliptin and are randomized in a double-blinded cross over fashion to pre-treatment with either Exendin 9-39 versus placebo.
|
|---|---|---|---|---|---|---|---|---|
|
Aim 1: First Intervention (1 Day)
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Effect of DPP4 Inhibition on Growth Hormone Secretion
Baseline characteristics by cohort
| Measure |
Participants From All Groups
n=39 Participants
Data was collected as one group
|
|---|---|
|
Age, Continuous
|
25 years
STANDARD_DEVIATION 5 • n=99 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
35 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Growth Hormone Level at 30 minutes (i.e. at completion of arginine infusion), 45 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesPopulation: Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.
Subjects underwent two study days separated by a washout period. On one study day they will receive sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine (30 grams i.v. over 30 minutes) on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 1: Stimulated Peak Growth Hormone Level
30 minutes
|
5.2 ng/ml
Standard Deviation 4.2
|
3.1 ng/ml
Standard Deviation 3.3
|
1.9 ng/ml
Standard Deviation 1.9
|
2.0 ng/ml
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
45 minutes
|
9.5 ng/ml
Standard Deviation 6.1
|
6.6 ng/ml
Standard Deviation 5.0
|
3.4 ng/ml
Standard Deviation 3.5
|
3.9 ng/ml
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
60 minutes
|
9.4 ng/ml
Standard Deviation 6.4
|
7.0 ng/ml
Standard Deviation 6.0
|
3.0 ng/ml
Standard Deviation 3.6
|
3.3 ng/ml
Standard Deviation 2.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
90 minutes
|
5.0 ng/ml
Standard Deviation 3.4
|
6.4 ng/ml
Standard Deviation 4.8
|
1.1 ng/ml
Standard Deviation 1.00
|
2.1 ng/ml
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
120 minutes
|
2.7 ng/ml
Standard Deviation 2.1
|
4.2 ng/ml
Standard Deviation 3.4
|
1.5 ng/ml
Standard Deviation 3.1
|
0.9 ng/ml
Standard Deviation 0.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
150 minutes
|
1.8 ng/ml
Standard Deviation 2.5
|
2.4 ng/ml
Standard Deviation 2.1
|
2.2 ng/ml
Standard Deviation 4.3
|
1.8 ng/ml
Standard Deviation 3.3
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Stimulated Peak Growth Hormone Level
180 minutes
|
0.9 ng/ml
Standard Deviation 0.9
|
1.3 ng/ml
Standard Deviation 1.9
|
1.0 ng/ml
Standard Deviation 1.9
|
1.0 ng/ml
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesForearm blood flow was determined by strain gauge plethysmography. Forearm vascular resistance was then calculated by dividing this into mean arterial pressure. The percent change from baseline was determined at each timepoint.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
30 minutes
|
-5.0677 percentage change from baseline
Standard Deviation 18.56794
|
-5.3498 percentage change from baseline
Standard Deviation 19.60881
|
1.4929 percentage change from baseline
Standard Deviation 21.57596
|
-11.2235 percentage change from baseline
Standard Deviation 13.60628
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
60 minutes
|
-5.1365 percentage change from baseline
Standard Deviation 16.61555
|
-1.0195 percentage change from baseline
Standard Deviation 22.62776
|
6.7355 percentage change from baseline
Standard Deviation 23.96889
|
4.6875 percentage change from baseline
Standard Deviation 31.77169
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
90 minutes
|
-10.1867 percentage change from baseline
Standard Deviation 22.00489
|
-1.6694 percentage change from baseline
Standard Deviation 31.84989
|
1.0144 percentage change from baseline
Standard Deviation 28.50393
|
-3.8029 percentage change from baseline
Standard Deviation 35.33295
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
120 minutes
|
-12.5192 percentage change from baseline
Standard Deviation 31.29272
|
-5.0763 percentage change from baseline
Standard Deviation 26.06546
|
-10.3674 percentage change from baseline
Standard Deviation 32.22945
|
-2.7449 percentage change from baseline
Standard Deviation 31.52281
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
150 minutes
|
-24.1962 percentage change from baseline
Standard Deviation 23.92090
|
-11.8335 percentage change from baseline
Standard Deviation 27.88447
|
-9.7129 percentage change from baseline
Standard Deviation 30.40280
|
-7.1590 percentage change from baseline
Standard Deviation 30.41909
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Vascular Resistance
180 minutes
|
-22.4043 percentage change from baseline
Standard Deviation 27.60020
|
-16.5358 percentage change from baseline
Standard Deviation 32.22119
|
-11.9609 percentage change from baseline
Standard Deviation 20.50786
|
-15.0591 percentage change from baseline
Standard Deviation 25.33331
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.Population: Data from all subjects who completed both study days in Aim 1 were analyzed. Subjects represented young, healthy adults without any chronic medical conditions and who did not take any medications. Oral birth control use was not permitted.
Forearm blood flow was determined by strain gauge plethysmography. The percent change from baseline was determined at each timepoint.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=29 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=10 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
30 minutes
|
0.4835 percent change from baseline
Standard Deviation 19.44436
|
1.6458 percent change from baseline
Standard Deviation 19.42502
|
-.0238 percent change from baseline
Standard Deviation 23.86278
|
9.2597 percent change from baseline
Standard Deviation 14.60368
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
60 minutes
|
5.3416 percent change from baseline
Standard Deviation 21.33943
|
4.9101 percent change from baseline
Standard Deviation 37.42841
|
-2.8869 percent change from baseline
Standard Deviation 25.79685
|
0.6789 percent change from baseline
Standard Deviation 24.91588
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
90 minutes
|
15.9192 percent change from baseline
Standard Deviation 36.11077
|
11.7285 percent change from baseline
Standard Deviation 47.44341
|
1.5212 percent change from baseline
Standard Deviation 30.57639
|
13.5358 percent change from baseline
Standard Deviation 37.76659
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
120 minutes
|
23.2248 percent change from baseline
Standard Deviation 40.83970
|
10.3081 percent change from baseline
Standard Deviation 28.31870
|
20.1185 percent change from baseline
Standard Deviation 38.89402
|
9.9379 percent change from baseline
Standard Deviation 28.93967
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
150 minutes
|
39.9269 percent change from baseline
Standard Deviation 45.00577
|
19.7355 percent change from baseline
Standard Deviation 30.90766
|
21.6011 percent change from baseline
Standard Deviation 42.67343
|
15.0944 percent change from baseline
Standard Deviation 34.56449
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Percent Change From Baseline in Forearm Blood Flow
180 minutes
|
40.6354 percent change from baseline
Standard Deviation 50.48606
|
30.0924 percent change from baseline
Standard Deviation 36.51124
|
16.8489 percent change from baseline
Standard Deviation 24.95539
|
26.1772 percent change from baseline
Standard Deviation 34.75120
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Percent change from baseline in forearm blood flow at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutes.Population: 19 of the original 29 females in Aim 1 returned to complete two more study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=2 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=2 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
n=5 Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
n=5 Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
n=7 Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
n=7 Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
n=1 Participants
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
n=1 Participants
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
120 minutes
|
4.22 percent change from baseline
Standard Error 12.54
|
9.80 percent change from baseline
Standard Error 18.23
|
32.92 percent change from baseline
Standard Error 0.97
|
56.26 percent change from baseline
Standard Error 55.06
|
54.10 percent change from baseline
Standard Error 21.87
|
41.97 percent change from baseline
Standard Error 31.29
|
31.10 percent change from baseline
Standard Error 9.04
|
22.24 percent change from baseline
Standard Error 11.14
|
16.52 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-22.00 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
150 minutes
|
16.09 percent change from baseline
Standard Error 13.00
|
11.26 percent change from baseline
Standard Error 28.45
|
26.27 percent change from baseline
Standard Error 13.73
|
71.51 percent change from baseline
Standard Error 76.00
|
59.08 percent change from baseline
Standard Error 32.36
|
26.87 percent change from baseline
Standard Error 17.56
|
29.48 percent change from baseline
Standard Error 8.22
|
15.59 percent change from baseline
Standard Error 8.26
|
45.98 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
1.33 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
180 minutes
|
14.80 percent change from baseline
Standard Error 15.85
|
17.12 percent change from baseline
Standard Error 20.53
|
29.24 percent change from baseline
Standard Error 35.21
|
65.31 percent change from baseline
Standard Error 80.28
|
51.21 percent change from baseline
Standard Error 26.07
|
43.51 percent change from baseline
Standard Error 26.31
|
30.76 percent change from baseline
Standard Error 8.88
|
27.11 percent change from baseline
Standard Error 12.21
|
54.91 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-1.67 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
30 minutes
|
-0.71 percent change from baseline
Standard Error 6.75
|
-9.34 percent change from baseline
Standard Error 8.60
|
5.17 percent change from baseline
Standard Error 4.27
|
14.78 percent change from baseline
Standard Error 14.78
|
15.64 percent change from baseline
Standard Error 5.06
|
0.39 percent change from baseline
Standard Error 8.93
|
-7.33 percent change from baseline
Standard Error 8.66
|
-0.98 percent change from baseline
Standard Error 12.08
|
-7.59 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-22.67 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
60 minutes
|
-3.64 percent change from baseline
Standard Error 12.68
|
-17.06 percent change from baseline
Standard Error 12.93
|
7.05 percent change from baseline
Standard Error 4.06
|
4.56 percent change from baseline
Standard Error 0.97
|
6.58 percent change from baseline
Standard Error 10.16
|
16.10 percent change from baseline
Standard Error 12.79
|
-10.54 percent change from baseline
Standard Error 8.53
|
6.95 percent change from baseline
Standard Error 9.53
|
9.37 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-13.00 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Blood Flow
90 minutes
|
3.24 percent change from baseline
Standard Error 10.02
|
-6.35 percent change from baseline
Standard Error 16.60
|
25.69 percent change from baseline
Standard Error 6.25
|
20.32 percent change from baseline
Standard Error 12.83
|
36.96 percent change from baseline
Standard Error 14.71
|
16.67 percent change from baseline
Standard Error 33.39
|
2.23 percent change from baseline
Standard Error 8.69
|
2.08 percent change from baseline
Standard Error 11.60
|
5.36 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-18.33 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
PRIMARY outcome
Timeframe: Percent change from baseline in forearm vascular resistance at 30 minutes, 60 minutes, 90 minutes, 120 minutes, 150 minutes, 180 minutesPopulation: 19 of the original 29 females who participated in Aim 1 returned to complete an additional two study days (Aim 2) in which they received sitagliptin + double-blinded study drug vs. sitagliptin plus placebo in a cross-over study. Three men from Aim 1 also returned to complete two more study days (Aim 2).
Subjects undergo two study days separated by a washout period. On one study day they will receive sitagliptin plus another study drug and on another sitagliptin plus placebo, in a randomized double-blind fashion. Forearm blood flow was assessed at each visit every 30 minutes for 3 hours. This was divided into mean arterial pressure to determine forearm vascular resistance.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=2 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=2 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
n=5 Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
n=5 Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
n=7 Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
n=7 Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
n=1 Participants
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
n=1 Participants
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
150 minutes
|
-13.25 percent change from baseline
Standard Error 8.49
|
42.27 percent change from baseline
Standard Error 44.03
|
-20.62 percent change from baseline
Standard Error 6.34
|
-32.11 percent change from baseline
Standard Error 24.34
|
-30.12 percent change from baseline
Standard Error 11.10
|
-14.25 percent change from baseline
Standard Error 13.15
|
-20.92 percent change from baseline
Standard Error 5.30
|
-8.49 percent change from baseline
Standard Error 9.03
|
-32.30 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
-1.32 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
180 minutes
|
-10.25 percent change from baseline
Standard Error 10.76
|
5.28 percent change from baseline
Standard Error 19.22
|
-22.56 percent change from baseline
Standard Error 13.90
|
-19.52 percent change from baseline
Standard Error 37.12
|
-25.00 percent change from baseline
Standard Error 11.92
|
-17.97 percent change from baseline
Standard Error 15.66
|
-22.58 percent change from baseline
Standard Error 5.82
|
-16.76 percent change from baseline
Standard Error 8.94
|
-34.69 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
1.69 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
30 minutes
|
-8.67 percent change from baseline
Standard Error 9.66
|
8.98 percent change from baseline
Standard Error 12.07
|
-9.87 percent change from baseline
Standard Error 0.82
|
-14.60 percent change from baseline
Standard Error 12.22
|
-20.00 percent change from baseline
Standard Error 3.67
|
-3.75 percent change from baseline
Standard Error 12.43
|
5.30 percent change from baseline
Standard Error 8.19
|
4.53 percent change from baseline
Standard Error 12.62
|
0.57 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
27.77 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
60 minutes
|
8.77 percent change from baseline
Standard Error 17.03
|
51.82 percent change from baseline
Standard Error 36.73
|
-9.75 percent change from baseline
Standard Error 2.28
|
-2.42 percent change from baseline
Standard Error 3.34
|
-4.05 percent change from baseline
Standard Error 10.67
|
-10.97 percent change from baseline
Standard Error 11.64
|
14.46 percent change from baseline
Standard Error 11.08
|
-4.26 percent change from baseline
Standard Error 7.26
|
-11.80 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
6.73 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
90 minutes
|
-4.89 percent change from baseline
Standard Error 8.93
|
39.24 percent change from baseline
Standard Error 35.45
|
-23.34 percent change from baseline
Standard Error 8.00
|
-16.75 percent change from baseline
Standard Error 4.25
|
-25.28 percent change from baseline
Standard Error 7.02
|
3.79 percent change from baseline
Standard Error 19.09
|
1.76 percent change from baseline
Standard Error 8.96
|
4.82 percent change from baseline
Standard Error 16.53
|
-14.02 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
22.45 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
|
Aim 2: Percent Change From Baseline in Forearm Vascular Resistance
120 minutes
|
0.99 percent change from baseline
Standard Error 11.00
|
21.98 percent change from baseline
Standard Error 35.57
|
-24.81 percent change from baseline
Standard Error 1.18
|
-28.34 percent change from baseline
Standard Error 21.27
|
-32.39 percent change from baseline
Standard Error 8.90
|
-14.57 percent change from baseline
Standard Error 18.78
|
-22.37 percent change from baseline
Standard Error 6.11
|
-13.16 percent change from baseline
Standard Error 10.34
|
-16.20 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
26.68 percent change from baseline
Standard Error NA
Cannot be determined with 1 participant.
|
SECONDARY outcome
Timeframe: baseline and every 30 minutes for 180 minutesPopulation: Data from the first 14 subjects (7 men and 7 women) who completed both study days in Aim 1 were analyzed. We do not report tPA results from the remaining participants as the manufacturer changed the tPA assay standard and results were not comparable.
In Aim 1 subjects underwent two study days separated by a washout period. On one study day they received study drug and on another placebo, in a randomized double-blind fashion. Venous blood samples were obtained at each visit.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
n=7 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
Baseline prior to Arginine
|
0.30 IU/ml
Standard Error 0.05
|
0.28 IU/ml
Standard Error 0.05
|
0.44 IU/ml
Standard Error 0.14
|
0.22 IU/ml
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
30 minutes
|
0.40 IU/ml
Standard Error 0.04
|
0.32 IU/ml
Standard Error 0.04
|
0.28 IU/ml
Standard Error 0.08
|
0.25 IU/ml
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
60 minutes
|
0.40 IU/ml
Standard Error 0.06
|
0.32 IU/ml
Standard Error 0.05
|
0.37 IU/ml
Standard Error 0.09
|
0.34 IU/ml
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
150 minutes
|
0.44 IU/ml
Standard Error 0.04
|
0.41 IU/ml
Standard Error 0.04
|
0.42 IU/ml
Standard Error 0.12
|
0.37 IU/ml
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
45 minutes
|
0.43 IU/ml
Standard Error 0.04
|
0.35 IU/ml
Standard Error 0.04
|
0.40 IU/ml
Standard Error 0.10
|
0.32 IU/ml
Standard Error 0.08
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
90 minutes
|
0.39 IU/ml
Standard Error 0.07
|
0.35 IU/ml
Standard Error 0.06
|
0.34 IU/ml
Standard Error 0.09
|
0.27 IU/ml
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
120 minutes
|
0.40 IU/ml
Standard Error 0.07
|
0.35 IU/ml
Standard Error 0.04
|
0.38 IU/ml
Standard Error 0.12
|
0.28 IU/ml
Standard Error 0.07
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 1: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
180 minutes
|
0.55 IU/ml
Standard Error 0.06
|
0.50 IU/ml
Standard Error 0.05
|
0.51 IU/ml
Standard Error 0.12
|
0.45 IU/ml
Standard Error 0.09
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and every 30 minutes until 180 minutesPopulation: Five of the original 29 women returned for two more study days separated by a wash-out. As pre-specified in the protocol, men did not complete this portion of the study. We do not report tPA results from participants who received LNMMA and Exendin 9-39 in this table as the manufacturer changed the tPA assay standard and results were not comparable.
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Tissue plasminogen activator activity (tPA) was assessed at each visit.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=5 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=5 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
180 minutes
|
0.35 IU/ml
Standard Error 0.06
|
0.23 IU/ml
Standard Error 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
Baseline prior to Arginine
|
0.24 IU/ml
Standard Error 0.05
|
0.10 IU/ml
Standard Error 0.03
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
30 minutes
|
0.26 IU/ml
Standard Error 0.04
|
0.15 IU/ml
Standard Error 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
45 minutes
|
0.33 IU/ml
Standard Error 0.06
|
0.17 IU/ml
Standard Error 0.06
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
60 minutes
|
0.27 IU/ml
Standard Error 0.08
|
0.14 IU/ml
Standard Error 0.04
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
90 minutes
|
0.26 IU/ml
Standard Error 0.07
|
0.16 IU/ml
Standard Error 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
120 minutes
|
0.28 IU/ml
Standard Error 0.08
|
0.16 IU/ml
Standard Error 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Venous Blood Sampling for Tissue Plasminogen Activator (TPA) Activity Levels
150 minutes
|
0.31 IU/ml
Standard Error 0.07
|
0.20 IU/ml
Standard Error 0.05
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: baseline and every 30 minutes until 180 minutesPopulation: Five of the original 29 women returned for an additional two study days separated by a wash-out period. As pre-specified in the protocol, men did not complete this portion of the study. We did not measure GH levels in participants who received LNMMA or Exendin 9-39 as these drugs are not known to influence GH secretion.
Subjects undergo two study days separated by a washout period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized double-blind fashion. Growth hormone secretion following arginine stimulation was assessed at each visit. Growth hormone levels were determined using an assay that is not subject to interference by pegvisomant.
Outcome measures
| Measure |
Aim 1: Sitagliptin,Female Participants
n=5 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Female Participants
n=5 Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Sitagliptin, Male Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 1: Placebo, Male Participants
Subjects underwent two study days separated by a washout period. On one study day they received sitagliptin and on another placebo, in a randomized double-blind fashion. Growth hormone secretion was stimulated using arginine on each study day. Growth hormone levels were assessed during a 3 hour period following arginine stimulation.
|
Aim 2: Sitagliptin and Pegvisomant, Female Participants
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin & Placebo, Females in Pegvisomant Group
Five of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus pegvisomant and on another sitagliptin plus placebo, in a randomized cross-over fashion. The protocol specified a priori not to study men further if the first seven men randomized to sitagliptin vs. placebo in Aim 1 showed no effect of sitagliptin in men.
|
Aim 2: Sitagliptin and Exendin 9-39, Female Participants
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Females in Exendin 9-39 Group
Seven of the original 29 women returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Exendin 9-39, Male Participant
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
Aim 2: Sitagliptin and Placebo, Male in Exendin 9-39 Group
One of the men from Aim 1 returned for an additional two study days separated by a wash-out period. On one study day they received sitagliptin plus Exendin 9-39 and on another sitagliptin plus placebo, in a randomized cross-over fashion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
30 minutes
|
2.99 ng/mL
Standard Error 1.60
|
4.27 ng/mL
Standard Error 2.19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
60 minutes
|
5.92 ng/mL
Standard Error 2.37
|
7.00 ng/mL
Standard Error 2.20
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
90 minutes
|
6.05 ng/mL
Standard Error 2.39
|
11.53 ng/mL
Standard Error 4.67
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
120 minutes
|
4.06 ng/mL
Standard Error 2.18
|
6.17 ng/mL
Standard Error 1.21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
150 minutes
|
1.83 ng/mL
Standard Error 0.83
|
4.09 ng/mL
Standard Error 1.33
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Aim 2: Measurement of Growth Hormone (GH) Levels
180 minutes
|
1.57 ng/mL
Standard Error 0.82
|
1.77 ng/mL
Standard Error 0.32
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Sitagliptin
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sitagliptin Plus Pegvisomant
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sitagliptin Plus LNMMA
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Sitagliptin Plus Exendin 9-39
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin
n=40 participants at risk
Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
|
Placebo
n=43 participants at risk
Healthy lean adults completed a double blinded cross over study in which they took sitagliptin vs. placebo separated by a wash-out.
|
Sitagliptin Plus Pegvisomant
n=5 participants at risk
Five women from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus pre-treatment with pegvisomant.
|
Sitagliptin Plus LNMMA
n=9 participants at risk
9 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus L-N-mono-methylarginine (LNMMA).
|
Sitagliptin Plus Exendin 9-39
n=8 participants at risk
8 participants from Aim 1 returned for an additional two study days in which they were randomized to sitagliptin plus placebo vs. sitagliptin plus Exendin 9-39.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Bruising related to placement of intravenous catheter
|
7.5%
3/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
2.3%
1/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Ear and labyrinth disorders
Nasal congestion
|
2.5%
1/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Gastrointestinal disorders
Reflux
|
2.5%
1/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Nervous system disorders
Dizziness and paresthesias during arginine infusion
|
0.00%
0/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
20.0%
1/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
|
Gastrointestinal disorders
Abdominal cramping and diarrhea
|
0.00%
0/40 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/43 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
20.0%
1/5 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/9 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
0.00%
0/8 • The first subject started drug 2/11/13 and the last completed 2/10/2017. In Aim 1, each subject took oral study drug (placebo vs. sitagliptin). Adverse event data was collected over a one month period for each subject. In Aim 2, each subject took oral sitagliptin and also received a single dose of LNMMA, Exendin 9-39 or Pegvisomant based upon their subgroup assigment. Adverse event data was collected over a 6 week period for each subject.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place