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CompletedNCT02973477Updated Oct 22, 2020Results posted

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

A Phase 4 interventional study of Dapagliflozin and Glimepiride in Type2 Diabetes and Cardiovascular Diseases, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by University of Michigan · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the effect of dapagliflozin, a FDA approved diabetes medication, on measures of nervous system function of the heart in patients with type 2 diabetes. The investigators will compare the effect of dapagliflozin with an active comparator, glimepiride (a different FDA approved diabetes medication) on measures of heart rate variability and assess whether dapagliflozin has modulating effects on measures of nervous system function of the heart. This is a crossover study design where all participants will receive both study medications equally (12-week intervention periods) in a certain order.

Read the detailed description

Study rationale: Empagliflozin and dapagliflozin are sodium-glucose transporter-2 (SGLT-2) inhibitors which prevent the reabsorption of glucose via proximal renal tubules, and are the most recently approved class for treating hyperglycemia in type 2 diabetes. Besides effective glucose lowering effects as documented by \~ 0.7-1.2% HbA1c reduction, these agents also promote weight loss and reduce blood pressure (BP). Furthermore, recent data from the Empagliflozin Cardiovascular Outcome Trial in type 2 diabetes (EMPA-REG OUTCOME) reported significant reduction in main cardiovascular disease (CVD) outcomes and CVD death in patients with type 2 diabetes (T2D). The exact mechanism of the beneficial effects on cardiovascular outcomes is not yet understood, although their effects on body weight, glucose control and BP reduction were suggested. However, other classes of drugs with similar effects such as GLP-1 receptor agonist, thiazolidinedione did not clearly show the beneficial effects in CVD outcomes. The interesting observation is that improvement in BP with SGLT-2 inhibitors occurred without a compensatory increase in HR and that most benefit was obtained also in patients with some evidence of heart failure.

Thus, the investigators postulated the hypothesis that SGLT-2 may also have a modulatory effect on the sympathetic/parasympathetic balance, and this may contribute to the potential benefits on cardiovascular outcomes in patients with diabetes.

Study Design: The investigators plan to test this hypothesis in a randomized, double-blind, 2-period crossover clinical trial comparing 12-weeks of glycemic intervention with dapagliflozin versus glimepiride. The investigators include an active comparator with glimepiride which have a similar glucose lowering in patients with T2D, to account for the effects of reductions in blood glucose on measures of CAN, and will evaluate whether changes in measures of CAN are different among patients who are taking glimepiride or dapagliflozin. The two crossover periods will be separated by a 2-week wash-out period.

All subjects will be allocated and randomized to each treatment sequence. Participants will receive blindly either dapagliflozin 5 mg or glimepiride 2 mg 1 tablet daily initially for 4 weeks then titrating the dose based on blood glucose levels up to 2 tablets daily for 8 more weeks (total 12 weeks) followed by 2-week washout period and then they will receive the study drugs in reverse order to the first period during second crossover period for 12 weeks.

Study population: 45 patients with T2D on background metformin monotherapy who are not meeting ADA recommended glycemic target.

Primary outcomes: changes in measures of cardiovascular autonomic neuropathy such as heart rate variability (HRV) as defined by frequency domain measures of HRV: low frequency (LF) power (ms2); high frequency (HF) power (ms2) as measured as LF:HF ratio.

Secondary outcomes: (i) changes in measures of HRV as defined by time domain measures of HRV: standard deviation of the normal RR interval (SDNN) (msec) and root mean square of the differences of successive RR intervals (rmsSD) (msec); (ii) changes in cardiovascular autonomic reflex tests (CARTs) as defined by: expiration/inspiration (E/I) ratio, Valsalva ratio, and 30:15 ratio; (iii) changes in measures of systolic and diastolic function will be assessed by using stress echocardiogram and evaluate the following measures: i) LVEF, ii) LV end diastolic volume, iii) LV end systolic volume, iv) LV mass, v) cardiac output.

02

Conditions studied

  • Type2 Diabetes
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 45 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with type 2 diabetes as defined on background metformin monotherapy who are not meeting ADA standard of care recommended glucose target.
  2. Age ≥18 years

Exclusion criteria

Exclusion Criteria:

  1. History of multiple urinary tract infections
  2. Patients with mycotic infections especially genital infections.
  3. Patients at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics should have careful monitoring of their volume status. This is listed as exclusion criteria but then it says that they just need careful monitoring. Is it an exclusion or not?
  4. Severely hypotensive patients
  5. History of unexplained microscopic or gross hematuria, or microscopic hematuria at visit 1, confirmed by a follow-up sample at next scheduled visit.
  6. Presence of hypersensitivity to dapagliflozin or other SGLT2 inhibitors (e.g. anaphylaxis, angioedema, exfoliative skin conditions
  7. Inability or refusal to comply with protocol
  8. Current participation or participation in an experimental drug study in the previous three months
  9. History of diabetic ketoacidosis
  10. Planned cardiac surgery or angioplasty within 3 months
  11. Recent history of acute CV events such as MI, stroke, PAD within 3 months prior to enrollment
  12. Patients with severe renal impairment or unstable or rapidly progressing renal disease or end stage renal disease.
  13. Clinical conditions that could interfere with the cardiovascular autonomic function and heart rate variability (arrhythmias)
  14. Severe hepatic insufficiency and/or significant abnormal liver function (defined as aspartate aminotransferase >3× upper limit of normal (ULN) and/or alanine aminotransferase >3× ULN) or creatinine kinase >3× ULN.
  15. History of cancer other than basal cell carcinoma and/or treatment for cancer within the last 5 years
  16. Women of child-bearing potential who may be pregnant or lactating.
  17. History of pancreas, kidney or liver transplant
  18. History of drug or alcohol abuse
  19. History of allergy to sulfa drugs
  20. Presence of any condition that, in the opinion of the investigator would make it unlikely for the subject to complete the study
  21. Congestive heart failure (CHF) defined as New York Heart Association class III and IV
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Investigator)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Group A: Dapagliflozin/Glimepiride

    Participants will take open-label dapagliflozin 5 mg daily for 4 weeks and escalate the dose gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin. Patients will then begin a 2 week washout period where they are not taking any study drugs. After the washout period, participants will receive open-label glimepiride 2 mg daily for 4 weeks and escalate the dose gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride.

    Drug: Dapagliflozin · Drug: Glimepiride

  • Experimental
    Group B: Glimepiride/Dapagliflozin

    Participants will take open-label glimepiride 2 mg daily for 4 weeks and escalate the dose gradually up to glimepiride 4 mg daily (no more than 4 mg daily) as needed based on their glucose monitoring for a total of 12 weeks on glimepiride. Patients will then begin a 2 week washout period where they are not taking any study drugs. After the washout period, participants will receive open-label dapagliflozin 5 mg daily for 4 weeks and escalate the dose gradually up to dapagliflozin 10 mg daily as needed based on their glucose monitoring for a total of 12 weeks on dapagliflozin.

    Drug: Dapagliflozin · Drug: Glimepiride

Interventions

  • DrugDapagliflozin

    Dapagliflozin is a sodium glucose transporter-2 (SGLT-2) inhibitor, a new class of glucose lowering agent that reduces hyperglycemia in patients with T2D by reducing renal glucose reabsorption.

    Also known as: Study Drug

  • DrugGlimepiride

    Glimepiride is a sulfonylurea agent that reduces hyperglycemia in patients with T2D by stimulating insulin release from the pancreatic beta cells and reduction of glucose output from the liver.

    Also known as: Active Comparator

06

What researchers measure

Primary outcomes

  1. Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.

    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.

    Time frame: from first baseline to end of 12 weeks' treatment and from second baseline (following 2 weeks of washout) to end of 12 weeks' treatment

Secondary outcomes

  1. Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.

    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).

    Time frame: 12 weeks on each intervention

  2. Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)

    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.).

    Time frame: 12 weeks on each intervention

  3. Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function

    Changes in B-type Natriuretic Peptide (BNP) with each intervention as a measure of left ventricular function.

    Time frame: 12 weeks for each intervention

Other outcomes

  1. Glucose Variability

    Measures of glucose variability via the continuous glucose monitoring system Libre Pro

    Time frame: 2 weeks on each intervention

07

Results

Posted Oct 22, 2020

Participant flow

First Intervention
Participant flow — First Intervention
MilestoneFirst Dapagliflozin Then GlimepirideFirst Glimepiride Then Dapagliflozin
Started1926
Completed1924
Not completed02
Withdrew: Lost to follow-up02
Washout
Participant flow — Washout
MilestoneFirst Dapagliflozin Then GlimepirideFirst Glimepiride Then Dapagliflozin
Started1924
Completed1824
Not completed10
Withdrew: Withdrawal by subject10
Second Intervention
Participant flow — Second Intervention
MilestoneFirst Dapagliflozin Then GlimepirideFirst Glimepiride Then Dapagliflozin
Started1824
Completed1724
Not completed10
Withdrew: Lost to follow-up10

Outcome measures

PrimaryChanges in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.

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.

Time frame:
from first baseline to end of 12 weeks' treatment and from second baseline (following 2 weeks of washout) to end of 12 weeks' treatment
Reported as:
Mean · LF:HF ratio
Changes in Measure of Heart Rate Variability Using Dapagliflozin vs Active Comparator Glimepiride.
LF:HF ratioFirst Dapagliflozin Then GlimepirideFirst Glimepiride Then Dapagliflozin
value at 12 weeks minus value at 1st baseline-0.18 ± 1.51-0.34 ± 1.54
value at 26 weeks minus value at 2nd baseline0.26 ± 1.850.26 ± 1.92
Statistical analysis
  • First Dapagliflozin Then Glimepiride vs First Glimepiride Then Dapagliflozin · Mixed Models Analysis · p = 0.28 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.) · Coefficient: 0.28 · 95% CI -0.24 to 0.8The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.
SecondaryChanges in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.

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).

Time frame:
12 weeks on each intervention
Reported as:
Mean · msec
Changes in Measures of Heart Rate Variability (HRV) Using Dapagliflozin vs Active Comparator Glimepiride.
msecParticipants Who Received Dapagliflozin InterventionParticipants Who Received Glimepiride Intervention
SDNN before treatment40.72 ± 16.6339.75 ± 16.15
SDNN after treatment37.74 ± 16.0436.46 ± 17.68
rmsSD before treatment26.91 ± 17.8125.14 ± 13.06
rmsSD after treatment24.30 ± 16.4424.63 ± 17.38
Statistical analysis
  • Participants Who Received Dapagliflozin Intervention vs Participants Who Received Glimepiride Intervention · Mixed Models Analysis · p = 0.97 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.) · Coefficient: -0.003 · 95% CI -0.16 to 0.15The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.
  • Participants Who Received Dapagliflozin Intervention vs Participants Who Received Glimepiride Intervention · Mixed Models Analysis · p = 0.79 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.) · Coefficient: -0.02 · 95% CI -0.21 to 0.16The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.
SecondaryChanges in Measures of Cardiac Autonomic Reflex Testing (CARTs)

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.).

Time frame:
12 weeks on each intervention
Reported as:
Mean · ratio
Changes in Measures of Cardiac Autonomic Reflex Testing (CARTs)
ratioAll Participants Who Received DapagliflozinAll Participants Who Received Glimiperide
E/I ratio before treatment1.13 ± 0.071.14 ± 0.08
EI ratio after treatment1.14 ± 0.111.14 ± 0.13
Valsalva ratio before treatment1.50 ± 0.361.44 ± 0.29
Valsalva ratio after treatment1.60 ± 0.661.58 ± 0.85
30:15 ratio before treatment1.17 ± 0.151.14 ± 0.09
30:15 ratio after treatment1.14 ± 0.111.14 ± 0.10
Statistical analysis
  • All Participants Who Received Dapagliflozin vs All Participants Who Received Glimiperide · Mixed Models Analysis · p = 0.58 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.) · Coefficient: 0.01 · 95% CI -0.02 to 0.04
  • All Participants Who Received Dapagliflozin vs All Participants Who Received Glimiperide · Mixed Models Analysis · p = 0.58 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for Valsalva ratio.) · Coefficient: 0.02 · 95% CI -0.05 to 0.09The outcome was logged in the model. The outcome was the natural log of that variable and the coefficient and CI are for the relationship with the log of the outcome.
  • All Participants Who Received Dapagliflozin vs All Participants Who Received Glimiperide · Mixed Models Analysis · p = 0.56 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome. Coefficient provided for 30:15 ratio.) · Coefficient: -0.01 · 95% CI -0.05 to 0.03
SecondaryChange in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function

Changes in B-type Natriuretic Peptide (BNP) with each intervention as a measure of left ventricular function.

Time frame:
12 weeks for each intervention
Reported as:
Mean · pg/ml
Change in B-type Natriuretic Peptide With Each Intervention as a Measure of Left Ventricular Function
pg/mlAll Participants Who Received DapagliflozinAll Participants Who Received Glimepiride
BNP before treatment12.72 ± 9.7616.93 ± 13.69
BNP after treatment14.76 ± 13.4115.49 ± 11.58
Statistical analysis
  • All Participants Who Received Dapagliflozin vs All Participants Who Received Glimepiride · Mixed Models Analysis · p = 0.92 (Adjusted analysis used a linear mixed effects model with unstructured covariance matrix controlled for possible period and sequence (carryover) effects for the outcome.) · Coefficient: 0.01 · 95% CI -0.23 to 0.25
Other pre-specifiedGlucose Variability

Measures of glucose variability via the continuous glucose monitoring system Libre Pro

Time frame:
2 weeks on each intervention

Results for this outcome have not been posted.

Adverse events

Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Dapagliflozin0/44 (0%)1/44 (2.3%)11/44 (25%)
Glimepiride0/43 (0%)0/43 (0%)14/43 (32.6%)
Not on Drug0/45 (0%)0/45 (0%)5/45 (11.1%)
Most frequent serious events
Most frequent serious events
EventDapagliflozinGlimepirideNot on Drug
Pulmonary EmbolismBlood and lymphatic system disorders1/440/430/45
Most frequent other events
Showing 10 of 31
Most frequent other events
EventDapagliflozinGlimepirideNot on Drug
Urinary Frequency and Discomfort - UTI Ruled OutRenal and urinary disorders0/442/430/45
HypoglycemiaEndocrine disorders1/442/430/45
Genital Yeast InfectionInfections and infestations2/440/430/45
Cold Like SymptomsInfections and infestations2/440/431/45
Vasovagal EpisodeNervous system disorders0/441/430/45
Stomach VirusInfections and infestations0/441/430/45
Atrial FibrillationCardiac disorders0/441/430/45
Chest PainCardiac disorders0/441/430/45
Basal Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/441/430/45
BronchitisInfections and infestations0/441/430/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)First Dapagliflozin Then GlimepirideFirst Glimepiride Then DapagliflozinTotal
Mean57 ± 956 ± 857 ± 8
Sex: Female, Male
Sex: Female, Male(Participants)First Dapagliflozin Then GlimepirideFirst Glimepiride Then DapagliflozinTotal
Female71219
Male121426
Race (NIH/OMB)
Race (NIH/OMB)(Participants)First Dapagliflozin Then GlimepirideFirst Glimepiride Then DapagliflozinTotal
American Indian or Alaska Native000
Asian202
Native Hawaiian or Other Pacific Islander000
Black or African American5712
White121830
More than one race000
Unknown or Not Reported011
LF:HF Ratio
LF:HF Ratio(Ratio)First Dapagliflozin Then GlimepirideFirst Glimepiride Then DapagliflozinTotal
Baseline before First Intervention1.00 ± 1.740.73 ± 1.310.84 ± 1.49
Baseline before Second Intervention0.82 ± 1.320.35 ± 1.360.61 ± 1.46
08

Study locations

1 site
  • University of Michigan
    Ann Arbor, Michigan 48104, United States
09

References and documents

Publications

  • Ang L, Kidwell KM, Dillon B, Reiss J, Fang F, Leone V, Mizokami-Stout K, Pop-Busui R. Dapagliflozin and measures of cardiovascular autonomic function in patients with type 2 diabetes (T2D). J Diabetes Complications. 2021 Aug;35(8):107949. doi: 10.1016/j.jdiacomp.2021.107949. Epub 2021 May 15. PubMed 34024686 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 10, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02973477
Lead sponsor
University of Michigan
Collaborators
AstraZeneca
Responsible party
Rodica Pop-Busui (Professor of Internal Medicine, University of Michigan) — Principal investigator
First posted
Nov 25, 2016
Start date
Jan 12, 2017
Primary completion
Aug 22, 2019
Completion
Aug 22, 2019
Results posted
Oct 22, 2020
Last update
Oct 22, 2020

Study contacts

Rodica Pop-Busui, M.D. Ph.D
principal investigator · University of Michigan Department of Internal Medicine Division of Metabolism, Endocrinology and Diabetes
Lynn P Ang, M.D
principal investigator · University of Michigan Department of Internal Medicine Division of Metabolism, Endocrinology and Diabetes

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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