Trial Outcomes & Findings for Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes (NCT NCT01951339)
NCT ID: NCT01951339
Last Updated: 2023-07-12
Results Overview
Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of study medication.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
36 participants
Primary outcome timeframe
Pre-intervention (Baseline) and post-intervention (3 months)
Results posted on
2023-07-12
Participant Flow
Patients underwent screening, as well as baseline data collection prior to randomization to group. Several patients withdrew from the study prior to randomization.
Participant milestones
| Measure |
Sitagliptin Plus Placebo
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Sitagliptin Plus Placebo
n=13 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=14 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 2 • n=5 Participants
|
57 years
STANDARD_DEVIATION 3 • n=7 Participants
|
57 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Subjects' peak oxygen consumption will be tested on a stationary bike before and after 3 months of study medication.
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=13 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=14 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Peak Oxygen Consumption (VO2peak).
Pre-intervention
|
1893 ml/min
Standard Deviation 138
|
1953 ml/min
Standard Deviation 113
|
|
Peak Oxygen Consumption (VO2peak).
Post-intervention
|
1849 ml/min
Standard Deviation 135
|
1881 ml/min
Standard Deviation 151
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=7 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=8 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant
Pre-intervention
|
34.1 seconds
Standard Deviation 7.3
|
30.9 seconds
Standard Deviation 3.9
|
|
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant
Post-intervention
|
26.6 seconds
Standard Deviation 2.9
|
29.6 seconds
Standard Deviation 3.6
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Oxygen uptake kinetics will be tested on a stationary bike before and after 3 months of study medication. VO2 kinetics is reported as the time constant associated with the change in oxygen update from rest to steady state.
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=13 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=14 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Change in Oxygen Uptake Kinetics (VO2 Kinetics)
Pre-intervention
|
56.2 seconds
Standard Deviation 5.0
|
54.2 seconds
Standard Deviation 7.3
|
|
Change in Oxygen Uptake Kinetics (VO2 Kinetics)
Post-intervention
|
67.5 seconds
Standard Deviation 8.0
|
54.6 seconds
Standard Deviation 4.3
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Population: These data are quality control measures only.
Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment. Data are represented as the change in Pi through the scan.
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=14 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=15 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in 31P Measurement: Free Pi Time Constant
Pre-intervention
|
29.73 seconds
Standard Deviation 10.16
|
28.54 seconds
Standard Deviation 10.44
|
|
Changes From Baseline in 31P Measurement: Free Pi Time Constant
Post-intervention
|
27.94 seconds
Standard Deviation 3.82
|
26.15 seconds
Standard Deviation 5.60
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Population: These data are quality control measures only.
Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=14 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=15 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks
Pre-intervention
|
8.19 mM
Standard Deviation 0.22
|
7.93 mM
Standard Deviation 0.58
|
|
Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks
Post-intervention
|
12.66 mM
Standard Deviation 13.59
|
8.02 mM
Standard Deviation 0.29
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=7 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=8 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant
Pre-intervention
|
28.0 seconds
Standard Deviation 5.3
|
24.5 seconds
Standard Deviation 3.5
|
|
Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant
Post-intervention
|
19.4 seconds
Standard Deviation 1.1
|
21.2 seconds
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Population: These data are quality control measures only.
Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=14 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=15 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in 31P Measurement: pH
Pre-intervention
|
6.88 pH
Standard Deviation 0.05
|
6.88 pH
Standard Deviation 0.05
|
|
Changes From Baseline in 31P Measurement: pH
Post-intervention
|
6.85 pH
Standard Deviation 0.02
|
6.89 pH
Standard Deviation 0.05
|
SECONDARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Potential change in cardiac function will be assessed by echocardiography before and after 3 months of study medication
Outcome measures
| Measure |
Sitagliptin Plus Placebo
n=13 Participants
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=14 Participants
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Changes From Baseline in Echocardiographic Measures (Stroke Volume)
Pre-intervention
|
58.2 mL/beat
Standard Deviation 5.5
|
72.7 mL/beat
Standard Deviation 6.1
|
|
Changes From Baseline in Echocardiographic Measures (Stroke Volume)
Post-intervention
|
64.6 mL/beat
Standard Deviation 11.9
|
77.8 mL/beat
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Pre-intervention (Baseline) and post-intervention (3 months)Population: This variable was listed as a secondary outcome of the study that was later dropped by the investigators after a careful review of the literature. We decided not to pursue this outcome because it was not scientifically useful to address the original hypothesis.
Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.
Outcome measures
Outcome data not reported
Adverse Events
Sitagliptin Plus Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Glimepiride Plus Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sitagliptin Plus Placebo
n=15 participants at risk
100 mg sitagliptin plus 2 mg placebo once daily for three months
Sitagliptin: 100 mg sitagliptin
Placebo: 2 mg placebo once daily
|
Glimepiride Plus Placebo
n=15 participants at risk
2 mg glimepiride plus 100 mg placebo once daily for three months
Glimepiride: Active Comparator
2mg glimepiride
Placebo: 100 mg placebo once daily for three months
|
|---|---|---|
|
Gastrointestinal disorders
Medication side effects
|
20.0%
3/15 • Number of events 3 • Adverse event data were collected during individual study participation, approximately 6 months.
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during individual study participation, approximately 6 months.
|
|
Metabolism and nutrition disorders
High blood glucose
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during individual study participation, approximately 6 months.
|
0.00%
0/15 • Adverse event data were collected during individual study participation, approximately 6 months.
|
|
Metabolism and nutrition disorders
Mild hypoglycemia
|
6.7%
1/15 • Number of events 1 • Adverse event data were collected during individual study participation, approximately 6 months.
|
13.3%
2/15 • Number of events 2 • Adverse event data were collected during individual study participation, approximately 6 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place