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

A Phase 4, Randomized, Open-label, Active-controlled, Multicenter Study to Evaluate the Renal Protective Effect (UACR), Efficacy and Safety of Ipragliflozin in Type 2 Diabetes Mellitus Patients With Albuminuria

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Astellas Pharma Korea, Inc. · Industry
• Sex: All
• Age: 19 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	metformin	oral
DRUG	ipragliflozin	oral
DRUG	glimepiride	oral

Timeline

• Start date: 2017-04-25
• Primary completion: 2018-12-12
• Completion: 2018-12-12
• First posted: 2017-04-18
• Last updated: 2024-11-08

Locations

8 sites across 1 country: South Korea