Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria

Type 2 Diabetes Mellitus With Diabetic Nephropathy Clinical Trial

Official title: A Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study Evaluating the Safety and Efficacy of Oral GKT137831 in Patients With Type 2 Diabetes and Albuminuria

Status Completed

Clinical Trial Summary

NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4 inhibitor.

The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone system.

Clinical Trial Description

A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study assessing a 12-week period of treatment with oral GKT137831 administered in addition to standard of care for patients with type 2 diabetes. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetes Mellitus, Type 2
• Diabetic Nephropathies
• Type 2 Diabetes Mellitus With Diabetic Nephropathy

• NCT number: NCT02010242
• Study type: Interventional
• Source: Genkyotex Innovation SAS
• Status: Completed
• Phase: Phase 2
• Start date: October 2013
• Completion date: March 2015