Trial · NCT02973477

Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)

NCT02973477, Phase 4, Completed, University of Michigan; results first posted 2020-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D). Trials, record NCT02973477. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02973477

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Trial

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

Title: Dapagliflozin and Measures of Cardiovascular Autonomic Function in Patients With Type 2 Diabetes (T2D)
NCT number: NCT02973477
Status: Completed
Phases: Phase 4
Enrollment: 45 participants, actual
Lead sponsor: University of Michigan
Conditions: Type2 Diabetes, Cardiovascular Diseases
Interventions: Dapagliflozin, Glimepiride
First posted: 2016-11-25
Last updated: 2020-10-22
Results first posted: 2020-10-22

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	from first baseline to end of 12 weeks' treatment and from second baseline (following 2 weeks of washout) to end of 12 weeks' treatment	Heart Rate Variability, as shown by the difference of the LF:HF ratio from baseline to 12 weeks per arm (two 12-week periods with a 2-week washout period. The frequency domain measures \[ low-frequency (LF) power (0.04-0.15 Hz), high-frequency (HF) power (0.15-0.4 Hz), and LF:HF ratio\] are obtained by spectral analysis of R-R interval from continuous electrocardiogram recordings to evaluate for sympathetic/parasympathetic (autonomic nervous function) balance.
Secondary	Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	12 weeks on each intervention	Changes in measures of HRV as defined by: Time domain measures of HRV (continuous variables): (i) standard deviation of the normal RR interval (SDNN) (msec) and (ii) root mean square of the differences of successive RR intervals (rmsSD) (msec). Time domain (SDNN and rmsSD) measures of the normal R-R intervals are derived from HRV studies using a physiologic monitor (Nightingale PPM2; Zoe Medical Inc.) under paced breathing, reflecting parasympathetic activity. Time domain measures of the normal R-R intervals, basically reflecting parasympathetic activity, include: the difference between the longest and shortestR-R interval, standard deviation of 5-min average of normal R-R intervals (SDANN), root-mean square of the difference of successive R-R intervals (rMSSD).
Secondary	Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)	12 weeks on each intervention	Changes in CARTs as defined by: i) expiration/inspiration (E/I) ratio, ii) Valsalva ratio and iii) 30:15 ratio. Cardiovascular autonomic reflex tests assess the cardiovascular autonomic function using provocative physiological maneuvers under paced breathing \[R-R response to breathing (E:I ratio), to Valsalva maneuver (Valsalva ratio) and to postural changes (30:15 ratio)\] at baseline and at the end of each study drug period using a physiologic monitor (Nightingale PPM2; Zoe Medical Inc.).
Secondary	Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function	12 weeks for each intervention	Changes in B-type Natriuretic Peptide (BNP) with each intervention as a measure of left ventricular function.
Other	Glucose Variability	2 weeks on each intervention	Measures of glucose variability via the continuous glucose monitoring system Libre Pro

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	from first baseline to end of 12 weeks' treatment and from second baseline (following 2 weeks of washout) to end of 12 weeks' treatment	All participants who completed both interventions were included in the analysis.	LF:HF ratio	MEAN
SECONDARY	Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	12 weeks on each intervention	All who started an intervention were included in analysis for Before treatment. Only those who completed it are included in After treatment. Changes in numbers represent participants from an arm leaving before completing an intervention. Since 3 people who began Glimepiride did not complete it, the 44 shown in Before reduces to 41 After.	msec	MEAN
SECONDARY	Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)	12 weeks on each intervention	All who started an intervention were included in Before rows if data was present. Only those who completed it are included in After treatment. Changes in numbers represent participants from an arm leaving before completing an intervention. Since 3 people who began Glimepiride did not complete it, the 44 shown in Before reduces to 41 After.	ratio	MEAN
SECONDARY	Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function	12 weeks for each intervention	1 Glimiperide-first person's BNP measurement for Before treatment was missing. Only those who completed it are included in After treatment. Changes in numbers represent participants from an arm leaving before completing an intervention. Since 2 others who began Glimepiride did not complete it, the 43 shown in Before reduces to 41 After.	pg/ml	MEAN
OTHER_PRE_SPECIFIED	Glucose Variability	2 weeks on each intervention

Source ClinicalTrials.gov

Results by group28

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

Outcome	Group	Category	Value	Spread	Units
Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	First Dapagliflozin Then Glimepiride	value at 12 weeks minus value at 1st baseline	-0.18	Standard Deviation 1.51	LF:HF ratio
Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	First Glimepiride Then Dapagliflozin	value at 12 weeks minus value at 1st baseline	-0.34	Standard Deviation 1.54	LF:HF ratio
Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	First Dapagliflozin Then Glimepiride	value at 26 weeks minus value at 2nd baseline	0.26	Standard Deviation 1.85	LF:HF ratio
Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.	First Glimepiride Then Dapagliflozin	value at 26 weeks minus value at 2nd baseline	0.26	Standard Deviation 1.92	LF:HF ratio
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Dapagliflozin Intervention	SDNN before treatment	40.72	Standard Deviation 16.63	msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Glimepiride Intervention	SDNN before treatment	39.75	Standard Deviation 16.15	msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Dapagliflozin Intervention	SDNN after treatment	37.74	Standard Deviation 16.04	msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Glimepiride Intervention	SDNN after treatment	36.46	Standard Deviation 17.68	msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Dapagliflozin Intervention	rmsSD before treatment	26.91	Standard Deviation 17.81	msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.	Participants Who Received Glimepiride Intervention	rmsSD before treatment	25.14	Standard Deviation 13.06	msec

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention	STARTED	First Dapagliflozin Then Glimepiride	19
First Intervention	STARTED	First Glimepiride Then Dapagliflozin	26
First Intervention	COMPLETED	First Dapagliflozin Then Glimepiride	19
First Intervention	COMPLETED	First Glimepiride Then Dapagliflozin	24
First Intervention	NOT COMPLETED	First Dapagliflozin Then Glimepiride	0
First Intervention	NOT COMPLETED	First Glimepiride Then Dapagliflozin	2
Washout	STARTED	First Dapagliflozin Then Glimepiride	19
Washout	STARTED	First Glimepiride Then Dapagliflozin	24
Washout	COMPLETED	First Dapagliflozin Then Glimepiride	18
Washout	COMPLETED	First Glimepiride Then Dapagliflozin	24

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events96

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
other	Torn Left Hamstring	Injury, poisoning and procedural complications	Dapagliflozin	1	44
other	Torn Left Hamstring	Injury, poisoning and procedural complications	Glimepiride	0	43
other	Torn Left Hamstring	Injury, poisoning and procedural complications	Not on Drug	0	45
other	Genital Yeast Infection	Infections and infestations	Dapagliflozin	2	44
other	Genital Yeast Infection	Infections and infestations	Glimepiride	0	43
other	Genital Yeast Infection	Infections and infestations	Not on Drug	0	45
other	Cold Like Symptoms	Infections and infestations	Dapagliflozin	2	44
other	Cold Like Symptoms	Infections and infestations	Glimepiride	0	43
other	Cold Like Symptoms	Infections and infestations	Not on Drug	1	45
other	Vasovagal Episode	Nervous system disorders	Dapagliflozin	0	44

1 to 10 of 96Source ClinicalTrials.gov

See all 96 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Dapagliflozin	0	44
Total, all-cause mortality	Glimepiride	0	43
Total, all-cause mortality	Not on Drug	0	45
Total, other adverse events	Dapagliflozin	11	44
Total, other adverse events	Glimepiride	14	43
Total, other adverse events	Not on Drug	5	45
Total, serious adverse events	Dapagliflozin	1	44
Total, serious adverse events	Glimepiride	0	43
Total, serious adverse events	Not on Drug	0	45

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34024686	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 comparisons0

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

None in this release.

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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GET https://conductscience.org/api/trials/v1/NCT02973477/results?page=2

API reference For AI assistants