The primary purpose of this study is to assess the renal protective effect of ipragliflozin in combination with metformin on the percent change of UACR from baseline to 24 weeks against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria. The secondary purpose of this study is to assess the efficacy, safety and impact on quality of life (QoL) of ipragliflozin in combination with metformin against glimepiride in combination with metformin in type 2 diabetes mellitus patients with albuminuria.
This is a multicenter study that will compare ipragliflozin/metformin with glimepiride/metformin in the treatment of type 2 diabetes mellitus (T2DM) with albuminuria. The study will include screening and 24-week treatment period. Subjects entering the study have been on a stable dose of at least 1000 mg/day metformin monotherapy for at least 8 weeks (56 days) prior to Visit 1. For randomization, subject will be stratified by the site and the administration of renin-angiotensin system inhibitors (angiotensin receptor blockers and/or angiotensin-converting-enzyme inhibitors) at Visit 2. Subjects will be centrally randomized to either ipragliflozin/metformin group or glimepiride/metformin group and receive 24-week treatment by each group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Site 13
Busan, South Korea
Site 02
Deagu, South Korea
Site 11
Guri-si, South Korea
Site 01
Seoul, South Korea
Site 05
Seoul, South Korea
Site 07
Seoul, South Korea
Site 09
Seoul, South Korea
Site 12
Suwon, South Korea
The percentage of change of Urine Albumin-to-Creatinine Ratio (UACR)
Early morning urinary sample will be collected for the test
Time frame: Baseline up to 24 weeks
The percentage of patients whose UACR level is normalized or improved more than 50%
Early morning urinary sample will be collected for the test
Time frame: 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
Time frame: Baseline up to 24 weeks
Change from baseline in Hemoglobin A1c (HbA1c)
Test parameter HbA1c shall be measured at the local laboratory
Time frame: Baseline up to 24 weeks
Change from baseline in Fasting Plasma Glucose (FPG)
Test parameter FPG shall be measured at the local laboratory
Time frame: 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
Time frame: 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
Time frame: Baseline up to 24 weeks
Change from baseline in Uric Acid
Test parameter Uric Acid shall be measured at the local laboratory
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to 24 weeks
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