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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 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

metformin

oral

DRUG

ipragliflozin

oral

DRUG

glimepiride

oral

Sponsors & Collaborators

  • Astellas Pharma Korea, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Astellas Pharma Korea, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03118713 on ClinicalTrials.gov