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New diabetes drugs under Real-World watch: 15,000 patients enrolled

NCT ID NCT05926414

Disease control Sponsor: Daewoong Pharmaceutical 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study is observing 15,000 adults with type 2 diabetes who are starting Envlo or Envlomet SR tablets. Researchers will check how well these drugs control blood sugar (HbA1c) over 24 weeks and monitor for side effects. The goal is to see if they work safely in everyday medical practice.

What this could mean

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

Active substance
Enavogliflozin (Envlo tablet or Envlomet SR tablet)
What this could lead to
If successful, this could confirm that Envlo or Envlomet SR helps control blood sugar in type 2 diabetes patients in real-world settings.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only follows patients for 24 weeks, so long-term effects are unknown.

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.

Participants

About 15,000 people

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

Started

Sep 2023

Expected to finish

Dec 2025

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.

Who is studied

This study is an observational study conducted in a single group, and was calculated using the Confidence Intervals for One Mean method for the mean by referring to the average and standard deviation of changes at 12 or 24 weeks compared to the baseline of HbA1c levels in previous phase 2 and 3 clinical trials

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: 1. an adult male and female over 19 years of age 2. A person who is a type 2 diabetic and is planed to take Envlo Tab or Envloment SR Tab for the first time according to the medical judgment of the Investigator based on the permit 3. A person who voluntarily participates in the observational study and agrees in writing to comply with the subject's precautions during the study period after hearing and understanding the detailed explanation of the characteristics of the observational study and the drug to be studied Exclusion Criteria: 1. Persons with diabetes other than type 2 diabetes (type 1 diabetes, diabetic ketoacidosis, gestational diabetes, etc.) 2. A person who is prohibited from administering in accordance with the permission of Envlo Tab.'s * Patients who overreact to Envlo Tab. or Envlo Tab. components and have a history of it * eGFR (estimated global filtration rate) patients below 30 mL/min/1.73 m2, end-stage renal disease or on dialysis * Patients with moderate and severe liver failure (AST or ALT \> 3x normal upper limit, Total Bilirubin \> 2x normal upper limit, hepatitis or liver failure) * Class III or IV by classification of the New York Heart Association (NYHA) 3. Patients with unstable weight due to treatment or other treatments (surgery, diet, etc.) with obesity or weight loss medication within 3 months of Enrollment 4. Pregnant women and lactating women 5. A person who participates in another clinical trial and is administering (applying) clinical trial drugs or clinical trial medical devices 6. A person who is deemed inappropriate to participate in this observational study based on the judgment of other investigators

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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

Contacts and locations

Locations

  • NaRi Kim

    Seoul, South Korea

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