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New diabetes drug DA-5218 aims to help when metformin Isn't enough

NCT ID NCT07229534

Disease control Sponsor: Dong-A ST Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an experimental drug called DA-5218 in 238 adults with type 2 diabetes whose blood sugar is not well controlled by metformin alone. Participants will receive either DA-5218 or an active comparator, and researchers will measure changes in HbA1c over time. The trial is double-blind and randomized, meaning neither patients nor doctors know who gets which treatment.

What this could mean

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

Active substance
DA-5218 (an experimental diabetes drug)
What this could lead to
If successful, DA-5218 could offer a new treatment option for people with type 2 diabetes who need better blood sugar control despite taking metformin.
What could go wrong
This is a Phase IV trial, so the drug is already approved in some form, but it may still have side effects or not work better than existing options. Results are limited to short-term blood sugar changes, not long-term outcomes.

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

About 238 people

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

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

19 years and older

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: * 7.0%≤HbA1c≤10.5% and fasting glucose≤270mg/dL * Treated with 1,000mg/day dose of metformin for at least 8 weeks Exclusion Criteria: * Type 1 diabetes mellitus, secondary diabetes mellitus or gestational diabetes mellitus * eGFR\<45mL/min/1.73m2 * ALT and AST 3 times or higher than upper normal range * Determined by investigator as unfit to participate in a clinical trial due to other reasons

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabete mellitus

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

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