Diabetes Mellitus, Type 2Phase 4SFRNDM2NCT05139914
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Endothelial Dysfunction, run by Boston University at 1 site in United States.
Trial summary
Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Endothelial Dysfunction
- What is being tested?
- Dapagliflozin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2022to 4 Feb 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of T2DM for minimum of 3 months defined as fasting glucose greater than or equal to 120 mg/dL, hemoglobin A1C (HbA1C) ≥6.5%
- Body mass index (BMI) >25
- Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
Who cannot join
- Treatment with anticoagulation
- Treatment with SGLT-2 inhibitor
- HbA1c >9.5% within the last 3 months
- Systolic blood pressure less than 120mm Hg
- History of genital mycotic infections: more than one genital mycotic infection in the past two years
- History of recurrent urinary tract infections: history of chronic cystitis and/or recurrent urinary tract infections (3 or more in the last year)
Show all 12Show fewer
- History of allergy to SGLT-2 inhibitor
- History of bladder cancer or prior pelvic radiation
- More than one hypoglycemic events in the past 6 months and/or HbA1c <7.0%
- Women lactating or pregnant. All women with childbearing potential will undergo a blood pregnancy test at each visit to exclude pregnancy.
- Treatment with an investigational product within the last 30 days.
- Clinically evident major illness of other organ systems, including clinically evident cancer, renal failure (GFR<60 mL/min), or other conditions that in the opinion of the principal investigator make a clinical study inappropriate
Trial locations and contacts
1 site in 1 country.
United States1 site
BU School of Medicine Evans 748
Boston, Massachusetts, 02118
About this study
Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood vessels.
The overarching objective of this mechanistic study is to learn how a Sodium-Glucose Cotransporter-2 (SGT2) inhibitor, dapagliflozin, impacts vascular health in patients with Type 2 Diabetes Mellitus (T2DM). The investigators will compare the changes in vascular health to changes in endothelial cell (EC) phenotype including non-coding RNA (ncRNA) to develop evidence supporting the mechanism of cardiovascular benefit of SGLT2 inhibitors. This study will provide novel information regarding the mechanism of effects of novel treatments for endothelial function and vascular health in patients with T2DM to reduce cardiovascular (CV) risk. The research aims to assess the:
- effects of dapagliflozin on EC phenotype.
- impact of dapagliflozin on vasodilator function and additional measures of vascular health including arterial stiffness and circulating markers of vascular health.
Read the detailed description
The study design is a two-treatment, two-period crossover, double-blind, placebo-controlled design study to investigate the effect of the SGLT2 inhibitor, dapagliflozin, on Endothelial Cell (EC) phenotype, EC RNA levels, circulating microRNA (miRNA), and biomarkers in patients with T2DM. Subjects will be randomized to treatment order in a 1:1 ratio to receive SGLT2 inhibitor (dapagliflozin) and then placebo or vice versa in a crossover design. Total study period for each study subject is 14 weeks consisting of: two treatment periods (dapagliflozin and placebo) lasting 6 weeks each (12 weeks total) and a 2 week washout period between treatment periods. Each subject undergoes a washout period of 2 weeks after completing first 6 weeks of treatment with either placebo or dapagliflozin. This is followed by crossover to the alternate treatment period of 6 weeks with dapagliflozin or placebo depending on their first treatment. Randomization will be done in block sizes of 2 or 4. Once assigned to treatment, participants will receive dapagliflozin 10 mg/day or placebo for 6 weeks.
The study was terminated due to the inability to enroll the anticipated 50 participants to test the research hypotheses (only 3 participants were randomized in almost 3 years). There were too few samples to test for endothelial cell related outcomes, miRNA, and biomarkers.
- Conditions
- Diabetes Mellitus, Type 2, Endothelial Dysfunction
- Being tested
- Dapagliflozin, Placebo
- Keywords
- Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor, Dapagliflozin, Endothelial cell (EC) Health, Vascular function, EC gene expression levels, Circulating miRNA, Biomarkers
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DapagliflozinDrug
Also called Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor
10 mg/day (in capsule form) of dapagliflozin for 6 weeks
PlaceboOther
Placebo capsule for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin then Placebo | Experimental | Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Receives: Drug: Dapagliflozin; Other: Placebo |
| Placebo then dapagliflozin | Placebo comparator | Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Receives: Drug: Dapagliflozin; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Systolic Blood Pressure
Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff
Measured: 14 weeks
Mean Diastolic Blood Pressure
Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2021
- Study start31 May 2022
- Primary completion4 Feb 2025
- Study completion4 Feb 2025
Why it stopped: The study was halted early because of the inability to enroll participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Naomi M Hamburg, MD, Principal investigator, BU School of Medicine, Cardiovascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05139914
- Sponsor's protocol ID
- H-41648
- Other IDs
- 20SFRN35120118
- Acronym
- SFRNDM2
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2021
- Last updated
- 11 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05139914
- Acronym / sponsor ID
- SFRNDM2 / H-41648
- Conditions
- Diabetes Mellitus, Type 2, Endothelial Dysfunction
- Keywords
- Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor, Dapagliflozin, Endothelial cell (EC) Health, Vascular function, EC gene expression levels, Circulating miRNA, Biomarkers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was halted early because of the inability to enroll participants.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 31 May 2022 (actual)
- Primary completion
- 4 Feb 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 1 Dec 2021 (actual)
- Results
- Posted 11 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Type 2 Diabetes Mellitus (T2DM) have changes in blood vessel health that can lead to a higher chance of developing heart attacks or strokes. New medications for T2DM including dapagliflozin, which is a Sodium-Glucose Cotransporter-2 inhibitor (SGLT2) inhibitor, may help protect the heart and blood vessels.
The overarching objective of this mechanistic study is to learn how a Sodium-Glucose Cotransporter-2 (SGT2) inhibitor, dapagliflozin, impacts vascular health in patients with Type 2 Diabetes Mellitus (T2DM). The investigators will compare the changes in vascular health to changes in endothelial cell (EC) phenotype including non-coding RNA (ncRNA) to develop evidence supporting the mechanism of cardiovascular benefit of SGLT2 inhibitors. This study will provide novel information regarding the mechanism of effects of novel treatments for endothelial function and vascular health in patients with T2DM to reduce cardiovascular (CV) risk. The research aims to assess the:
- effects of dapagliflozin on EC phenotype.
- impact of dapagliflozin on vasodilator function and additional measures of vascular health including arterial stiffness and circulating markers of vascular health.
Detailed description
The study design is a two-treatment, two-period crossover, double-blind, placebo-controlled design study to investigate the effect of the SGLT2 inhibitor, dapagliflozin, on Endothelial Cell (EC) phenotype, EC RNA levels, circulating microRNA (miRNA), and biomarkers in patients with T2DM. Subjects will be randomized to treatment order in a 1:1 ratio to receive SGLT2 inhibitor (dapagliflozin) and then placebo or vice versa in a crossover design. Total study period for each study subject is 14 weeks consisting of: two treatment periods (dapagliflozin and placebo) lasting 6 weeks each (12 weeks total) and a 2 week washout period between treatment periods. Each subject undergoes a washout period of 2 weeks after completing first 6 weeks of treatment with either placebo or dapagliflozin. This is followed by crossover to the alternate treatment period of 6 weeks with dapagliflozin or placebo depending on their first treatment. Randomization will be done in block sizes of 2 or 4. Once assigned to treatment, participants will receive dapagliflozin 10 mg/day or placebo for 6 weeks.
The study was terminated due to the inability to enroll the anticipated 50 participants to test the research hypotheses (only 3 participants were randomized in almost 3 years). There were too few samples to test for endothelial cell related outcomes, miRNA, and biomarkers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin then Placebo | Experimental | Drug: Dapagliflozin, Other: PlaceboParticipants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. |
| Placebo then dapagliflozin | Placebo comparator | Drug: Dapagliflozin, Other: PlaceboParticipants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of T2DM for minimum of 3 months defined as fasting glucose greater than or equal to 120 mg/dL, hemoglobin A1C (HbA1C) ≥6.5%
- Body mass index (BMI) >25
- Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.
Key exclusion criteria (12 listed)
- Treatment with anticoagulation
- Treatment with SGLT-2 inhibitor
- HbA1c >9.5% within the last 3 months
- Systolic blood pressure less than 120mm Hg
- History of genital mycotic infections: more than one genital mycotic infection in the past two years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DapagliflozinAlso: Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor10 mg/day (in capsule form) of dapagliflozin for 6 weeks | Drug | Dapagliflozin then Placebo, Placebo then dapagliflozin |
| PlaceboPlacebo capsule for 6 weeks | Other | Dapagliflozin then Placebo, Placebo then dapagliflozin |
Primary outcome
Mean Systolic Blood Pressure
Time frame: 14 weeks
Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff
Mean Diastolic Blood Pressure
Time frame: 14 weeks
Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Naomi M Hamburg, MD principal investigator
BU School of Medicine, Cardiovascular Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dapagliflozin in people with Diabetes Mellitus, Type 2 and Endothelial Dysfunction, run by Boston University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Systolic Blood Pressure (time frame: 14 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.