In this multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study, we aimed to test the non-inferiority of evogliptin vs linagliptin in terms of reduction of albuminuria at week 24 from baseline in patients with type 2 diabetes having renal insufficiency.
This is a multi-center, randomized, double-blind, active-controlled, phase II non-inferiority study. Evogliptin (Trade name, Suganon) is a new, novel dipeptidyl peptidase-4 (DPP4) inhibitor which reveals a favorable results on glucose-lowering effect in patients with diabetes. However, its effect on renal function in patients with diabetes has been uncertained. To compare the effect of evogliptin and linagliptin on the reduction of albuminuria, we will recruit a total of 210 patients with Type 2 diabetes and renal insufficiency and allocate the participants into evogliptin group and linagliptin group with a ratio of 1:1 after radomization from 10 hospitals. After the oral administration of evogliptin 5mg per day or linagliptin 5mg per day for 24 weeks, the percent change of urine albumin-to-creatinine ratio (UACR) at Week 24 and at baseline will be measured as a primary endpoint. In addition, the percent changes of UACR, hemoglobin A1c, Cystatin-C, Nephrin, N-acetyl-beta-D-glucosaminidase (NAG), glycated albumin, estimated glomerular filtration rate (eGFR) between baseline and Week 12 or Week 24 will be studied as secondary endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
209
This group will take daily evogliptin 5mg per oral, not linagliptin.
This group will take daily linagliptin 5mg per oral, not evogliptin
Samsung Medical Center
Seoul, South Korea
UACR percent change at Week 24
Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
Time frame: Week 24
UACR change at Week 24 (%)
Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%)
Time frame: Week 24
UACR change at Week 12
Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g
Time frame: Week 12
HbA1c change at Week 24
Change in glycated hemoglobin after 24 weeks compared to baseline
Time frame: Week 24
HbA1c change at Week 12
Change in glycated hemoglobin after 12 weeks compared to baseline
Time frame: Week 12
HbA1c less than 6.5% at Week 24
proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks
Time frame: Week 24
HbA1c less than 6.5% at Week 12
proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks
Time frame: Week 12
HbA1c less than 7.0% at Week 24
proportion of participants having glycated hemoglobin less than 7.0% after 24weeks
Time frame: Week 24
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HbA1c less than 7.0% at Week 12
proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks
Time frame: Week 12
NAG (N-acetyl-β-D-glucosaminidase) change at Week 24
Change in NAG (N-acetyl-β-D-glucosaminidase) after 24 weeks compared to baseline (U/L)
Time frame: Week 24
NAG (N-acetyl-β-D-glucosaminidase) change at Week 12
Change in NAG (N-acetyl-β-D-glucosaminidase) after 12 weeks compared to baseline (U/L)
Time frame: Week 12
Cystatin-C change at Week 24
Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L)
Time frame: Week 24
Cystatin-C change at Week 12
Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L)
Time frame: Week 12
Nephrin change at Week 24
Change in Nephrin after 24 weeks compared to baseline (ug/g cr)
Time frame: Week 24
Nephrin change at Week 12
Change in Nephrin after 12 weeks compared to baseline (ug/g cr)
Time frame: Week 12
Glycated albumin change at Week 24
Change in Glycated albumin after 24 weeks compared to baseline (%)
Time frame: Week 24
Glycated albumin change at Week 12
Change in Glycated albumin after 12 weeks compared to baseline (%)
Time frame: Week 12
eGFR at Week 24
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 24 weeks compared to baseline (mL/min)
Time frame: Week 24
eGFR change at Week 12
Change in estimated glomerular filtration rate based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) method after 12 weeks compared to baseline (mL/min)
Time frame: Week 12