drugset / Trial / NCT03118713

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

NCT03118713

Phase 4 Terminated 33 enrolled Astellas Pharma Inc
RandomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2017-04-25
Primary completion
2018-12-12
Completion
2018-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Glimepiride Small molecule Oral
Subject ipragliflozin Small molecule Oral
Background Metformin Small molecule Oral