NCT05139914TerminatedPhase 4
Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 11 Feb 2026
Reason given: The study was halted early because of the inability to enroll participants.
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 19 Nov 2021
- Start date
- 31 May 2022
- Primary completion date
- 4 Feb 2025
- Lead sponsor
- Boston University
- Diseases
- Type 2 diabetes
- NCT number
- NCT05139914
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with anticoagulation
- Treatment with SGLT-2 inhibitor
- History of bladder cancer or prior pelvic radiation
- Treatment with an investigational product within the last 30 days.
Other illness
- 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)
- History of allergy to SGLT-2 inhibitor
Lab values
- HbA1c >9.5% within the last 3 months
- More than one hypoglycemic events in the past 6 months and/or HbA1c <7.0%
- 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
Other
- Systolic blood pressure less than 120mm Hg
- Women lactating or pregnant. All women with childbearing potential will undergo a blood pregnancy test at each visit to exclude pregnancy.
Who the study is looking for
- 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.
Age in the registry: 30 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BU School of Medicine Evans 748 | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.