Assessment of Dapagliflozin on Vascular Health in Patients With Type 2 Diabetes

NCT05139914 | Terminated Phase 4 Results DMC FDA Drug

• 2 other identifiers: H-4164820SFRN35120118
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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 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.

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

Outcome Measures

Primary Outcomes (2)

• Mean Systolic Blood Pressure

  Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff

  14 weeks

• Mean Diastolic Blood Pressure

  Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff

  14 weeks

Study Arms (2)

Dapagliflozin then Placebo

EXPERIMENTAL

Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between.

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.

Drug: Dapagliflozin; Other: Placebo

Interventions

Dapagliflozin DRUG

10 mg/day (in capsule form) of dapagliflozin for 6 weeks

Also known as: Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor

Dapagliflozin then Placebo; Placebo then dapagliflozin

Placebo OTHER

Placebo capsule for 6 weeks

Dapagliflozin then Placebo; Placebo then dapagliflozin

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Boston University: lead
• American Heart Association: collaborator

Study Sites (1)

BU School of Medicine Evans 748

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Naomi Hamburg, MD
• Organization: BU School of Medicine, Cardiovascular Medicine

nhamburg@bu.edu

(617) 638-7260

Study Officials

• Naomi M Hamburg, MD

  BU School of Medicine, Cardiovascular Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 1, 2021
• Study Start: May 31, 2022
• Primary Completion: February 4, 2025
• Study Completion: February 4, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)