Trial · NCT01951339

Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes

NCT01951339, Not applicable, Completed, University of Colorado, Denver; results first posted 2019-05-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes. Trials, record NCT01951339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01951339

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Impact of Sitagliptin on Cardiovascular Exercise Performance in Type 2 Diabetes
NCT number: NCT01951339
Status: Completed
Phases: Not applicable
Enrollment: 36 participants, actual
Lead sponsor: University of Colorado, Denver
Conditions: Type 2 Diabetes, Cardiovascular Disease
Interventions: Sitagliptin, Glimepiride, Placebo, Placebo
First posted: 2013-09-26
Last updated: 2023-07-12
Results first posted: 2019-05-22

Source ClinicalTrials.gov

Registered outcomes9

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Peak Oxygen Consumption (VO2peak).	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.
Primary	Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)	Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Primary	Change in Oxygen Uptake Kinetics (VO2 Kinetics)	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.
Primary	Changes From Baseline in 31P Measurement: Free Pi Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)	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.
Primary	Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks	Pre-intervention (Baseline) and post-intervention (3 months)	Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Primary	Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)	Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Primary	Changes From Baseline in 31P Measurement: pH	Pre-intervention (Baseline) and post-intervention (3 months)	Potential change in muscle mitochondrial function will be assessed after three months of study medication treatment
Secondary	Changes From Baseline in Echocardiographic Measures (Stroke Volume)	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
Secondary	Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise	Pre-intervention (Baseline) and post-intervention (3 months)	Deoxygenated hemoglobin concentration will be measured using near-infrared spectroscopy during sub-maximal exercise before and after 3 months of study drug administration.

Source ClinicalTrials.gov

Outcomes9

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Peak Oxygen Consumption (VO2peak).	Pre-intervention (Baseline) and post-intervention (3 months)		ml/min	MEAN
PRIMARY	Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)		seconds	MEAN
PRIMARY	Change in Oxygen Uptake Kinetics (VO2 Kinetics)	Pre-intervention (Baseline) and post-intervention (3 months)		seconds	MEAN
PRIMARY	Changes From Baseline in 31P Measurement: Free Pi Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)	These data are quality control measures only.	seconds	MEAN
PRIMARY	Changes From Baseline in 31P Measurement: Adenosine Triphosphate (ATP) Peaks	Pre-intervention (Baseline) and post-intervention (3 months)	These data are quality control measures only.	mM	MEAN
PRIMARY	Changes From Baseline in 31P Measurement: Adenosine Diphosphate (ADP) Time Constant	Pre-intervention (Baseline) and post-intervention (3 months)		seconds	MEAN
PRIMARY	Changes From Baseline in 31P Measurement: pH	Pre-intervention (Baseline) and post-intervention (3 months)	These data are quality control measures only.	pH	MEAN
SECONDARY	Changes From Baseline in Echocardiographic Measures (Stroke Volume)	Pre-intervention (Baseline) and post-intervention (3 months)		mL/beat	MEAN
SECONDARY	Change in (Non-invasively Measured) Deoxygenated Hemoglobin Concentration in the Vastus Lateralis During Exercise	Pre-intervention (Baseline) and post-intervention (3 months)	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.

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Peak Oxygen Consumption (VO2peak).	Sitagliptin Plus Placebo	Pre-intervention	1893	Standard Deviation 138	ml/min
Peak Oxygen Consumption (VO2peak).	Glimepiride Plus Placebo	Pre-intervention	1953	Standard Deviation 113	ml/min
Peak Oxygen Consumption (VO2peak).	Sitagliptin Plus Placebo	Post-intervention	1849	Standard Deviation 135	ml/min
Peak Oxygen Consumption (VO2peak).	Glimepiride Plus Placebo	Post-intervention	1881	Standard Deviation 151	ml/min
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Sitagliptin Plus Placebo	Pre-intervention	34.1	Standard Deviation 7.3	seconds
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Glimepiride Plus Placebo	Pre-intervention	30.9	Standard Deviation 3.9	seconds
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Sitagliptin Plus Placebo	Post-intervention	26.6	Standard Deviation 2.9	seconds
Changes From Baseline in 31P Measurement: Phosphocreatine Time Constant	Glimepiride Plus Placebo	Post-intervention	29.6	Standard Deviation 3.6	seconds
Change in Oxygen Uptake Kinetics (VO2 Kinetics)	Sitagliptin Plus Placebo	Pre-intervention	56.2	Standard Deviation 5.0	seconds
Change in Oxygen Uptake Kinetics (VO2 Kinetics)	Glimepiride Plus Placebo	Pre-intervention	54.2	Standard Deviation 7.3	seconds

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Sitagliptin Plus Placebo	15
Overall Study	STARTED	Glimepiride Plus Placebo	15
Overall Study	COMPLETED	Sitagliptin Plus Placebo	13
Overall Study	COMPLETED	Glimepiride Plus Placebo	14
Overall Study	NOT COMPLETED	Sitagliptin Plus Placebo	2
Overall Study	NOT COMPLETED	Glimepiride Plus Placebo	1

Source ClinicalTrials.gov

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Medication side effects	Gastrointestinal disorders	Sitagliptin Plus Placebo	3	15	3
other	Medication side effects	Gastrointestinal disorders	Glimepiride Plus Placebo	1	15	1
other	High blood glucose	Metabolism and nutrition disorders	Sitagliptin Plus Placebo	1	15	1
other	High blood glucose	Metabolism and nutrition disorders	Glimepiride Plus Placebo	0	15	0
other	Mild hypoglycemia	Metabolism and nutrition disorders	Sitagliptin Plus Placebo	1	15	1
other	Mild hypoglycemia	Metabolism and nutrition disorders	Glimepiride Plus Placebo	2	15	2

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Sitagliptin Plus Placebo	0	15
Total, all-cause mortality	Glimepiride Plus Placebo	0	15
Total, other adverse events	Sitagliptin Plus Placebo	5	15
Total, other adverse events	Glimepiride Plus Placebo	3	15
Total, serious adverse events	Sitagliptin Plus Placebo	0	15
Total, serious adverse events	Glimepiride Plus Placebo	0	15

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31182338	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Sitagliptin Plus Placebo vs Glimepiride Plus Placebo: deaths from any cause	Trial comparisons
Sitagliptin Plus Placebo vs Glimepiride Plus Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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