| Trial ID: | L5424 |
| Source ID: | NCT03118713
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| Associated Drug: |
Metformin
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| Title: |
A Study to Evaluate the Renal Protective Effect (Urine Albumin-to-Creatinine Ratio (UACR)), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria
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| Acronym: |
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| Status: |
TERMINATED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Type 2 Diabetes Mellitus
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| Interventions: |
DRUG: metformin|DRUG: ipragliflozin|DRUG: glimepiride
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| Outcome Measures: |
Primary: The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR), Early morning urinary sample will be collected for the test, Baseline up to 24 weeks | Secondary: The percentage of patients whose UACR level is normalized or improved more than 50%, Early morning urinary sample will be collected for the test, Baseline up to 24 weeks|Change from baseline in Estimated glomerular filtration rate (e-GFR), Test parameter e-GFR shall be measured at the local laboratory, Baseline up to 24 weeks|Change from baseline in Hemoglobin A1c (HbA1c), Test parameter HbA1c shall be measured at the local laboratory, Baseline up to 24 weeks|Change from baseline in Fasting Plasma Glucose (FPG), Test parameter FPG shall be measured at the local laboratory, Baseline up to 24 weeks|Change from baseline in body weight, Body Weight shall be measured by the same scale for the clinical trial period, Baseline up to 24 weeks|Change from baseline in blood pressure, Blood pressure will be measured two times with 1-2 minutes interval by the same arm and procedure during the study, Baseline up to 24 weeks|Change from baseline in Uric Acid, Test parameter Uric Acid shall be measured at the local laboratory, Baseline up to 24 weeks|Change from baseline in health status as measured through EuroQol 5 Dimension 5 Level Health State Utility Index (EQ-5D-5L) questionnaire, The EQ-5D-5L Questionnaire consists of 5 domains: mobility, self-care, usual activities, pain/discomfort, anxiety/depression, Baseline up to 24 weeks|Change from baseline in health status as measured through EuroQol-Visual Analogue Scale (EQ VAS) questionnaire, The EQ VAS measures the score (0 to 100) of change from baseline to 24 weeks, Baseline up to 24 weeks|Change from baseline in Quality of Life as measured through Audit of Diabetes-Dependent Quality of Life-19 (ADDQoL-19) questionnaire, Quality of Life will be assessed through ADDQoL-19. Patients will be asked to complete the questionnaires at visit 2 and 5, Baseline up to 24 weeks
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| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Korea, Inc.
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE4
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| Enrollment: |
33
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2017-04-25
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| Completion Date: |
2018-12-12
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| Results First Posted: |
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| Last Update Posted: |
2024-11-08
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| Locations: |
Site 13, Busan, Korea, Republic of|Site 02, Deagu, Korea, Republic of|Site 11, Guri-si, Korea, Republic of|Site 01, Seoul, Korea, Republic of|Site 05, Seoul, Korea, Republic of|Site 07, Seoul, Korea, Republic of|Site 09, Seoul, Korea, Republic of|Site 12, Suwon-si, Korea, Republic of
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| URL: |
https://clinicaltrials.gov/show/NCT03118713
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