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Clinical Trial Details

Trial ID: L5945
Source ID: NCT03667300
Associated Drug: Evogliptin
Title: Effect of Evogliptin on Albuminuria in Patients With Type 2 Diabetes and Renal Insufficiency
Acronym: DA1229
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type2 Diabetes Mellitus|Albuminuria|Renal Insufficiency
Interventions: DRUG: Evogliptin|DRUG: Linagliptin
Outcome Measures: Primary: UACR percent change at Week 24, Percentage change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%), Week 24 | Secondary: UACR change at Week 24 (%), Change in urine albumin-to-creatinine ratio (UACR) after 24 weeks compared to baseline (%), Week 24|UACR change at Week 12, Change in urine albumin-to-creatinine ratio (UACR) after 12 weeks compared to baseline (mg/g, Week 12|HbA1c change at Week 24, Change in glycated hemoglobin after 24 weeks compared to baseline, Week 24|HbA1c change at Week 12, Change in glycated hemoglobin after 12 weeks compared to baseline, Week 12|HbA1c less than 6.5% at Week 24, proportion of parcipitants having glycated hemoglobin less than 6.5% after 24 weeks, Week 24|HbA1c less than 6.5% at Week 12, proportion of participants having glycated hemoglobin less than 6.5% after 12 weeks, Week 12|HbA1c less than 7.0% at Week 24, proportion of participants having glycated hemoglobin less than 7.0% after 24weeks, Week 24|HbA1c less than 7.0% at Week 12, proportion of participants having glycated hemoglobin less than 7.0% after 12 weeks, 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), 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), Week 12|Cystatin-C change at Week 24, Change in urinary Cystatin-C after 24 weeks compared to baseline (mg/L), Week 24|Cystatin-C change at Week 12, Change in urinary Cystatin-C after 12 weeks compared to baseline (mg/L), Week 12|Nephrin change at Week 24, Change in Nephrin after 24 weeks compared to baseline (ug/g cr), Week 24|Nephrin change at Week 12, Change in Nephrin after 12 weeks compared to baseline (ug/g cr), Week 12|Glycated albumin change at Week 24, Change in Glycated albumin after 24 weeks compared to baseline (%), Week 24|Glycated albumin change at Week 12, Change in Glycated albumin after 12 weeks compared to baseline (%), 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), 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), Week 12
Sponsor/Collaborators: Sponsor: Samsung Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 209
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-03-16
Completion Date: 2019-05-14
Results First Posted:
Last Update Posted: 2019-09-23
Locations: Samsung Medical Center, Seoul, 135-710, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03667300