Type 2 Diabetes MellitusPOLUSNCT07433192
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
An observational study of Type 2 Diabetes Mellitus, run by Servier Russia at 1 site in Russia.
Trial summary
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- How many people
- 300 participants
- Where
- 1 siteRussia
- Study dates
- 2 Mar 2026to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
Read the detailed description
This single-arm study is planned to include patients who, in routine clinical practice, have been prescribed 2.5 mg of Lusefi® once daily as type 2 diabetes treatment. If the response to the treatment is insufficient, the attending physician in routine clinical practice may increase the daily dose to 5 mg once daily. The total duration of observation within this study will be approximately 6 months.
Describing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.
- Conditions
- Type 2 Diabetes Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline
Measured: 6 months
Secondary outcomes (9)
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)
Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on Body weight
Change in Body weight (BW) at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on systolic blood pressure (SBP)
Change in systolic blood pressure (SBP) at Visit 3 compared to baseline
Measured: 6 months
Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)
Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on filtration function of the kidneys
Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on lipid profile (cholesterol )
Change in total cholesterol at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on lipid profile (lipoproteins )
Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on lipid profile (triglycerides )
Change in triglycerides (TG) at Visit 3 compared to baseline.
Measured: 6 months
Effectiveness of luseogliflozin on uric acid level
Change in uric acid level at Visit 3 compared to baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Mar 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servier Russia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marina Shestakova, Principal investigator, Endocrinology Research Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433192
- Sponsor's protocol ID
- IC4-LUS-004-RUS
- Acronym
- POLUS
- Status last verified
- Apr 2026
- First submitted
- 19 Feb 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.
- ClinicalTrials.gov ID
- NCT07433192
- Acronym / sponsor ID
- POLUS / IC4-LUS-004-RUS
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Servier RussiaIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.
Detailed description
This single-arm study is planned to include patients who, in routine clinical practice, have been prescribed 2.5 mg of Lusefi® once daily as type 2 diabetes treatment. If the response to the treatment is insufficient, the attending physician in routine clinical practice may increase the daily dose to 5 mg once daily. The total duration of observation within this study will be approximately 6 months.
Describing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)
Time frame: 6 months
Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline
9 secondary outcomes
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)
Time frame: 6 months
Effectiveness of luseogliflozin on Body weight
Time frame: 6 months
Effectiveness of luseogliflozin on systolic blood pressure (SBP)
Time frame: 6 months
Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)
Time frame: 6 months
Effectiveness of luseogliflozin on filtration function of the kidneys
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (cholesterol )
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (lipoproteins )
Time frame: 6 months
Effectiveness of luseogliflozin on lipid profile (triglycerides )
Time frame: 6 months
Effectiveness of luseogliflozin on uric acid level
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marina Shestakova principal investigator
Endocrinology Research Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 2 Diabetes Mellitus, run by Servier Russia at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Erina (+7 495 9370700, ekaterina.erina@servier.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.