Trial Outcomes & Findings for Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy (NCT NCT01859793)
NCT ID: NCT01859793
Last Updated: 2016-10-21
Results Overview
A measurement of endothelial function in humans
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
38 participants
Primary outcome timeframe
Change before and after a single dose (2 hours post) and 8 weeks after daily dosing
Results posted on
2016-10-21
Participant Flow
Participant milestones
| Measure |
Placebo 1st Then Sitagliptin
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period
|
Sitagliptin First Then Placebo
sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
|
|---|---|---|
|
First Intervention (8 Weeks)
STARTED
|
20
|
18
|
|
First Intervention (8 Weeks)
COMPLETED
|
15
|
17
|
|
First Intervention (8 Weeks)
NOT COMPLETED
|
5
|
1
|
|
Washout Period (4 Weeks)
STARTED
|
15
|
17
|
|
Washout Period (4 Weeks)
COMPLETED
|
14
|
16
|
|
Washout Period (4 Weeks)
NOT COMPLETED
|
1
|
1
|
|
2nd Intervention Period
STARTED
|
14
|
16
|
|
2nd Intervention Period
COMPLETED
|
14
|
16
|
|
2nd Intervention Period
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo 1st Then Sitagliptin
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period
|
Sitagliptin First Then Placebo
sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
|
|---|---|---|
|
First Intervention (8 Weeks)
Protocol Violation
|
2
|
0
|
|
First Intervention (8 Weeks)
Adverse Event
|
1
|
0
|
|
First Intervention (8 Weeks)
Withdrawal by Subject
|
2
|
1
|
|
Washout Period (4 Weeks)
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Effects of Sitagliptin on Endothelial Function in Type 2 Diabetes on Background Metformin Therapy
Baseline characteristics by cohort
| Measure |
Matching Placebo 1st
n=14 Participants
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally
|
Sitagliptin 1st
n=16 Participants
100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 10 • n=5 Participants
|
63 years
STANDARD_DEVIATION 9 • n=7 Participants
|
63 years
STANDARD_DEVIATION 9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
10 participants
n=5 Participants
|
15 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Body Mass Index
|
32.1 kg/m^2
STANDARD_DEVIATION 6.6 • n=5 Participants
|
32.6 kg/m^2
STANDARD_DEVIATION 6.3 • n=7 Participants
|
32.4 kg/m^2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
HgA1C
|
6.8 percent
STANDARD_DEVIATION 0.2 • n=5 Participants
|
6.9 percent
STANDARD_DEVIATION 0.8 • n=7 Participants
|
6.8 percent
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Heart Rate
|
72 bpm
STANDARD_DEVIATION 10 • n=5 Participants
|
76 bpm
STANDARD_DEVIATION 8 • n=7 Participants
|
74 bpm
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Systolic Blood Pressure
|
131 mmHg
STANDARD_DEVIATION 13 • n=5 Participants
|
136 mmHg
STANDARD_DEVIATION 15 • n=7 Participants
|
134 mmHg
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Diastolic Blood Pressure
|
73 mmHg
STANDARD_DEVIATION 11 • n=5 Participants
|
78 mmHg
STANDARD_DEVIATION 20 • n=7 Participants
|
75 mmHg
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Total Cholesterol
|
165 mg/dL
STANDARD_DEVIATION 31 • n=5 Participants
|
169 mg/dL
STANDARD_DEVIATION 29 • n=7 Participants
|
167 mg/dL
STANDARD_DEVIATION 30 • n=5 Participants
|
|
High Density Lipoprotein
|
55 mg/dL
STANDARD_DEVIATION 12 • n=5 Participants
|
56 mg/dL
STANDARD_DEVIATION 20 • n=7 Participants
|
55 mg/dL
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Low Density Lipoprotein
|
85 mg/dL
STANDARD_DEVIATION 29 • n=5 Participants
|
84 mg/dL
STANDARD_DEVIATION 26 • n=7 Participants
|
84 mg/dL
STANDARD_DEVIATION 27 • n=5 Participants
|
|
Triglycerides
|
126 mg/dL
STANDARD_DEVIATION 53 • n=5 Participants
|
138 mg/dL
STANDARD_DEVIATION 40 • n=7 Participants
|
132 mg/dL
STANDARD_DEVIATION 46 • n=5 Participants
|
|
Insulin
|
15.1 microU/mL
STANDARD_DEVIATION 5.6 • n=5 Participants
|
16.0 microU/mL
STANDARD_DEVIATION 8.9 • n=7 Participants
|
15.6 microU/mL
STANDARD_DEVIATION 7.4 • n=5 Participants
|
|
Glucose
|
117 mg/dL
STANDARD_DEVIATION 26 • n=5 Participants
|
134 mg/dL
STANDARD_DEVIATION 31 • n=7 Participants
|
126 mg/dL
STANDARD_DEVIATION 30 • n=5 Participants
|
|
Homeostatic Assessment of Insulin Resistance
|
4.4 units on a scale
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
4.9 units on a scale
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Alanine Aminotransferase (ALT)
|
30 mg/dL
STANDARD_DEVIATION 30 • n=5 Participants
|
28 mg/dL
STANDARD_DEVIATION 23 • n=7 Participants
|
29 mg/dL
STANDARD_DEVIATION 26 • n=5 Participants
|
|
Aspartate Aminotransferase (AST)
|
25 mg/dL
STANDARD_DEVIATION 17 • n=5 Participants
|
25 mg/dL
STANDARD_DEVIATION 13 • n=7 Participants
|
25 mg/dL
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Total Bilirubin
|
0.4 mg/dL
STANDARD_DEVIATION 0.2 • n=5 Participants
|
0.5 mg/dL
STANDARD_DEVIATION 0.3 • n=7 Participants
|
0.5 mg/dL
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Alkaline Phosphatase
|
73 mg/dL
STANDARD_DEVIATION 10 • n=5 Participants
|
78 mg/dL
STANDARD_DEVIATION 20 • n=7 Participants
|
78 mg/dL
STANDARD_DEVIATION 16 • n=5 Participants
|
|
History of Hypertension
With Hypertension
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
History of Hypertension
Without Hypertension
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
History of High Cholesterol
With Dyslipidemia
|
8 participants
n=5 Participants
|
13 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
History of High Cholesterol
Without Dyslipidemia
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Smoking Status
Never
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Smoking Status
Past or Current
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
ACE Inhibitor
Yes
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
ACE Inhibitor
No
|
4 participants
n=5 Participants
|
8 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Beta-Blocker
Yes
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Beta-Blocker
No
|
13 participants
n=5 Participants
|
15 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
HMG CoA-Reductase
Yes
|
9 participants
n=5 Participants
|
13 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
HMG CoA-Reductase
No
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change before and after a single dose (2 hours post) and 8 weeks after daily dosingPopulation: All 30 subjects who completed both arms of the cross-over study
A measurement of endothelial function in humans
Outcome measures
| Measure |
Matching Placebo
n=30 Participants
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally
|
Sitagliptin
n=30 Participants
100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally
|
|---|---|---|
|
Brachial Artery Flow Mediated Dilation
Prior To Intervention
|
5.2 %FMD
Standard Deviation 1.8
|
5.6 %FMD
Standard Deviation 2.3
|
|
Brachial Artery Flow Mediated Dilation
2 hours post acute dose
|
5.6 %FMD
Standard Deviation 2.1
|
6.3 %FMD
Standard Deviation 2.4
|
|
Brachial Artery Flow Mediated Dilation
Following 8 weeks of therapy
|
6.0 %FMD
Standard Deviation 2.9
|
5.8 %FMD
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medicationPopulation: 29 of the 30 subjects who completed both arms of the study. One subject was missing the measurements post 8 weeks of each intervention arm and was excluded
Outcome measures
| Measure |
Matching Placebo
n=29 Participants
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally
|
Sitagliptin
n=29 Participants
100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally
|
|---|---|---|
|
Circulating Inflammatory Marker ICAM-1
Pre-Intervention
|
226 mg/mL
Standard Deviation 72
|
223 mg/mL
Standard Deviation 73
|
|
Circulating Inflammatory Marker ICAM-1
2 hours post acute dose
|
216 mg/mL
Standard Deviation 73
|
211 mg/mL
Standard Deviation 68
|
|
Circulating Inflammatory Marker ICAM-1
post 8 weeks of therapy
|
228 mg/mL
Standard Deviation 73
|
232 mg/mL
Standard Deviation 74
|
SECONDARY outcome
Timeframe: Change before and after acute dose (2 hours) and 8 weeks after daily dosing of medicationPopulation: 29 of the 30 subject who completed the study. Once subject had missing data for the post-8 weeks of each intervention
Outcome measures
| Measure |
Matching Placebo
n=29 Participants
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally
|
Sitagliptin
n=29 Participants
100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally
|
|---|---|---|
|
Circulating Inflammatory Markers VCAM-1
Pre-Intervention
|
584 mg/mL
Standard Deviation 187
|
608 mg/mL
Standard Deviation 164
|
|
Circulating Inflammatory Markers VCAM-1
2 hours post acute dose
|
575 mg/mL
Standard Deviation 141
|
574 mg/mL
Standard Deviation 157
|
|
Circulating Inflammatory Markers VCAM-1
post 8 weeks of therapy
|
620 mg/mL
Standard Deviation 196
|
620 mg/mL
Standard Deviation 196
|
Adverse Events
Matching Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sitagliptin
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 |
Matching Placebo
n=36 participants at risk
Matching Placebo for Sitagliptin
Placebo: Matching placebo in appearance given once/day orally
|
Sitagliptin
n=32 participants at risk
100mg pill, PO administered once daily.
sitagliptin: 100 mg pill, administered once/day orally
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
2.8%
1/36 • Number of events 1 • 3 years
|
0.00%
0/32 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place