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

NCT07433192 | Recruiting

• 1 other identifier: IC4-LUS-004-RUS
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (9)

• Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)

  6 months

• Effectiveness of luseogliflozin on Body weight

  6 months

• Effectiveness of luseogliflozin on systolic blood pressure (SBP)

  6 months

• Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)

  6 months

• Effectiveness of luseogliflozin on filtration function of the kidneys

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

GBUZ hospital

Anapa, Russia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marina Shestakova

  Endocrinology Research Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ekaterina Erina

CONTACT

+7 495 9370700; ekaterina.erina@servier.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: February 25, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

RU (1)