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| ID | Type | Description | Link |
|---|---|---|---|
| 20SFRN35120118 | Other Grant/Funding Number | American Heart Association |
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The study was halted early because of the inability to enroll participants.
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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dapagliflozin then Placebo | Experimental | Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. |
|
| Placebo then dapagliflozin | Placebo Comparator | Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dapagliflozin | Drug | 10 mg/day (in capsule form) of dapagliflozin for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi M Hamburg, MD | BU School of Medicine, Cardiovascular Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BU School of Medicine Evans 748 | Boston | Massachusetts | 02118 | United States |
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4 participants were enrolled but 1 was ineligible after screening so that 3 were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dapagliflozin Then Placebo | Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks |
| FG001 | Placebo Then Dapagliflozin | Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dapagliflozin Then Placebo | Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks |
| BG001 | Placebo Then Dapagliflozin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Systolic Blood Pressure | Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff | Data were not analyzed for either study arm as there was only one participant in each arm at 14 weeks. | Posted | 14 weeks |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dapagliflozin Then Placebo | Participants in this arm will receive dapagliflozin and then placebo with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Hamburg, MD | BU School of Medicine, Cardiovascular Medicine | (617) 638-7260 | nhamburg@bu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2022 | Jan 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 28, 2021 | Jan 24, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C529054 | dapagliflozin |
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| Placebo | Other | Placebo capsule for 6 weeks |
|
Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Mean Diastolic Blood Pressure | Supine blood pressures were measure in triplicate after 10 minute rest period using Omron blood pressure cuff | Data were not analyzed for either study arm as there was only one participant in each arm at 14 weeks. | Posted | 14 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Placebo Then Dapagliflozin | Participants in this arm will receive placebo and then dapagliflozin with a 2 week wash out period in between. Dapagliflozin: 10 mg/day (in capsule form) of dapagliflozin for 6 weeks Placebo: Placebo capsule for 6 weeks | 0 | 2 | 0 | 2 | 0 | 2 |
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| D004700 | Endocrine System Diseases |