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Could a common diabetes drug tame ulcerative colitis?

NCT ID NCT05986136

Disease control Sponsor: Mostafa Bahaa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether dapagliflozin, a drug currently used for diabetes, can help control inflammation in people with mild-to-moderate ulcerative colitis. Researchers will give 50 adults either dapagliflozin plus standard mesalamine or mesalamine alone, and track changes in symptoms and colon inflammation. The goal is to see if adding dapagliflozin improves disease control without serious side effects.

What this could mean

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

Active substance
dapagliflozin (a diabetes drug) combined with mesalamine (a standard colitis drug)
What this could lead to
If it works, this could offer a new, well-tolerated treatment option for mild-to-moderate ulcerative colitis by reducing inflammation.
What could go wrong
This is a small, early-phase trial (50 people) testing a repurposed diabetes drug. It may not show significant benefit, and results may not apply to severe cases.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2023

Expected to finish

Jul 2028

An estimate. End dates often move.

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

18 months to 60 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: * Age ≥ 18 years * Both male and female will be * Mild and moderate UC patients diagnosed and confirmed by endoscope Exclusion Criteria: * Breast feeding * Significant liver and kidney function abnormalities * Colorectal cancer patients * Patients with severe UC * Patients taking rectal or systemic steroids * Patients taking immunosuppressives or biological therapies * Addiction to alcohol and / or drugs * Known allergy to the dapagliflozin

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Conditions

The condition(s) this trial relates to.

inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

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

Inflammatory bowel diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Faculty of Medicine, Mansoura University

    RECRUITING

    Al Mansurah, 7650001, Egypt

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