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New diabetes drug tested in everyday clinics

NCT ID NCT07433192

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is observing 300 adults with type 2 diabetes who are already taking luseogliflozin as part of their routine care. Researchers will track changes in blood sugar levels, body weight, and side effects over time. The goal is to see how well the drug works in real-world settings, outside of strict research conditions.

What this could mean

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

Active substance
luseogliflozin (a diabetes drug that helps lower blood sugar by making the kidneys remove more sugar in urine)
What this could lead to
If successful, this study could confirm that luseogliflozin works well and is safe for managing type 2 diabetes in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It is also early-stage and only includes patients already taking the drug, which may limit conclusions.

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 300 people

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

Started

Mar 2026

Expected to finish

Sep 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.

Who is studied

patients with type 2 diabetes in real-world clinical practice Every investigator is expected to include about 4 patients that meet the inclusion/exclusion criteria. Inclusion period will last up to 6 months.

Ages

18 years and older

Sex

Anyone

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: * Men and women aged 18 years and older. * Patients with type 2 diabetes. * Written informed consent of the patient to participate in the study. * No conditions that require emergency medical aid. * Treatment with luseogliflozin started 7 to 30 days prior to the inclusion visit as part of routine clinical practice and in accordance with the SmPC approved in the Russian Federation. * Presence of data on the parameters of interest (HbA1c, eGFR, BP, body weight), dated no later than 15 days from the date the treatment with luseogliflozin was started Exclusion Criteria: * Patients cannot be included in this study if they meet at least one of the following exclusion criteria: * Known hypersensitivity to luseogliflozin or other components of Lusefi®. * Type 1 diabetes. * Decompensated type 2 diabetes. * Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study. * Severe renal failure (eGFR \<30 mL/min/1.73 m2), end-stage chronic kidney disease (CKD) or dialysis, as the treatment is predicted to be ineffective in this population of patients. * Diabetic ketoacidosis, diabetic coma or precoma. * Severe infections, pre- and postoperative period, or severe injury. * Any suspected or confirmed malignant neoplasm, including a history of malignancy within ≤5 years prior to screening, excluding successfully treated basal cell carcinoma and squamous cell carcinoma of the skin or in situ cervical cancer. * Urinary tract infection (confirmed or suspected). * Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results. * Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator. * Participation of the patient in another clinical study within 3 months (6 months for biological medicinal products) prior to the inclusion visit or during this study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • GBUZ hospital

    RECRUITING

    Anapa, Russia

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