Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-31 @ 4:04 AM
Study NCT ID:
NCT07433192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-25
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-19', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (glycated hemoglobin)', 'timeFrame': '6 months', 'description': 'Change in glycated hemoglobin (HbA1c) level by the end of the observation period (Visit 3) compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemic effectiveness of luseogliflozin in patients with type 2 diabetes (plasma glucose)', 'timeFrame': '6 months', 'description': 'Change in fasting plasma glucose (FPG) level at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on Body weight', 'timeFrame': '6 months', 'description': 'Change in Body weight (BW) at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on systolic blood pressure (SBP)', 'timeFrame': '6 months', 'description': 'Change in systolic blood pressure (SBP) at Visit 3 compared to baseline'}, {'measure': 'Effectiveness of luseogliflozin on diastolic blood pressure ( DBP)', 'timeFrame': '6 months', 'description': 'Change in diastolic blood pressure (DBP) at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on filtration function of the kidneys', 'timeFrame': '6 months', 'description': 'Change in estimated glomerular filtration rate (eGFR) at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on lipid profile (cholesterol )', 'timeFrame': '6 months', 'description': 'Change in total cholesterol at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on lipid profile (lipoproteins )', 'timeFrame': '6 months', 'description': 'Change in low-density lipoproteins (LDLP) at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on lipid profile (triglycerides )', 'timeFrame': '6 months', 'description': 'Change in triglycerides (TG) at Visit 3 compared to baseline.'}, {'measure': 'Effectiveness of luseogliflozin on uric acid level', 'timeFrame': '6 months', 'description': 'Change in uric acid level at Visit 3 compared to baseline.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'In this non-interventional study, the effectiveness and tolerability of Lusefi® in adult patients with type 2 diabetes will be evaluated.', 'detailedDescription': '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.\n\nDescribing hypoglycemic effectiveness of luseogliflozin, its effect on the metabolic and hemodynamic parameters in patients with type 2 diabetes in real-world clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 years and older.\n* Patients with type 2 diabetes.\n* Written informed consent of the patient to participate in the study.\n* No conditions that require emergency medical aid.\n* 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.\n* 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\n\nExclusion Criteria:\n\n* Patients cannot be included in this study if they meet at least one of the following exclusion criteria:\n* Known hypersensitivity to luseogliflozin or other components of Lusefi®.\n* Type 1 diabetes.\n* Decompensated type 2 diabetes.\n* Pregnancy, breastfeeding, or planned pregnancy during the study and at least two months after the study.\n* 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.\n* Diabetic ketoacidosis, diabetic coma or precoma.\n* Severe infections, pre- and postoperative period, or severe injury.\n* 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.\n* Urinary tract infection (confirmed or suspected).\n* Other concomitant disorders considered by the investigator to affect the natural progression of the disease and significantly impact the treatment results.\n* Predictable unwillingness of the patient to adhere to the treatment regimen and/or cooperate with the investigator.\n* 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.'}, 'identificationModule': {'nctId': 'NCT07433192', 'acronym': 'POLUS', 'briefTitle': 'POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Servier Russia'}, 'officialTitle': 'Multicenter Observational Study POLUS: Description of the Effectiveness and Tolerability of Luseogliflozin in Patients With Type 2 Diabetes in Real-world Clinical Practice.', 'orgStudyIdInfo': {'id': 'IC4-LUS-004-RUS'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ekaterina Erina', 'role': 'CONTACT', 'email': 'ekaterina.erina@servier.com', 'phone': '+7 495 9370700'}], 'overallOfficials': [{'name': 'Marina Shestakova', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Endocrinology Research Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servier Russia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}