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

NCT ID: NCT05139914

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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 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.

Conditions

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Diabetes Mellitus, Type 2 Endothelial Dysfunction

Keywords

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Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor Dapagliflozin Endothelial cell (EC) Health Vascular function EC gene expression levels Circulating miRNA Biomarkers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dapagliflozin then Placebo

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

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

Placebo capsule for 6 weeks

Placebo then dapagliflozin

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

Group Type PLACEBO_COMPARATOR

Dapagliflozin

Intervention Type DRUG

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

Placebo

Intervention Type OTHER

Placebo capsule for 6 weeks

Interventions

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Dapagliflozin

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

Intervention Type DRUG

Placebo

Placebo capsule for 6 weeks

Intervention Type OTHER

Other Intervention Names

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Sodium-Glucose Cotransporter-2 (SGLT2) inhibitor

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Boston University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naomi M Hamburg, MD

Role: PRINCIPAL_INVESTIGATOR

BU School of Medicine, Cardiovascular Medicine

Locations

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BU School of Medicine Evans 748

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Naomi Hamburg, MD

Role: CONTACT

Phone: (617) 638-7260

Email: [email protected]

Facility Contacts

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Naomi M Hamburg, MD

Role: primary

Leili Behrooz, MD

Role: backup

Other Identifiers

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20SFRN35120118

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-41648

Identifier Type: -

Identifier Source: org_study_id