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Diabetes Drug's heart benefits probed in tiny, terminated study

NCT ID NCT05139914

Knowledge-focused Sponsor: Boston University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aimed to see how dapagliflozin, a diabetes drug, affects blood vessel health in people with type 2 diabetes. Researchers planned to measure blood pressure and other markers of vascular function. However, the trial was terminated early and only enrolled 4 participants, so the findings are very limited.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin
What this could lead to
If successful, this could help explain how dapagliflozin protects the heart and blood vessels in people with type 2 diabetes.
What could go wrong
The trial was terminated early with only 4 participants, so results are very limited and may not be reliable. It was a small, early-stage mechanistic study.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

4 people

The number who actually took part.

Started

May 2022

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Endothelial dysfunction

Contacts and locations

Locations

  • BU School of Medicine Evans 748

    Boston, Massachusetts, 02118, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.