POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes. (POLUS)

April 29, 2026 updated by: Servier Russia

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Anapa, Russia
        • Recruiting
        • GBUZ hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)
Time Frame: 6 months
Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on Body weight
Time Frame: 6 months
Change in Body weight (BW) at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on systolic blood pressure (SBP)
Time Frame: 6 months
Change in systolic blood pressure (SBP) at Visit 3 compared to baseline
6 months
Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)
Time Frame: 6 months
Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on filtration function of the kidneys
Time Frame: 6 months
Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on lipid profile (cholesterol )
Time Frame: 6 months
Change in total cholesterol at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on lipid profile (lipoproteins )
Time Frame: 6 months
Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on lipid profile (triglycerides )
Time Frame: 6 months
Change in triglycerides (TG) at Visit 3 compared to baseline.
6 months
Effectiveness of luseogliflozin on uric acid level
Time Frame: 6 months
Change in uric acid level at Visit 3 compared to baseline.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Servier Russia

Investigators

  • Principal Investigator: Marina Shestakova, Endocrinology Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 19, 2026

First Submitted That Met QC Criteria

February 19, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC4-LUS-004-RUS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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