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

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.

Timeline

Start

2013-10

Primary completion

2015-02

Completion

2015-03

Outcome

Missed primary endpoint

registry analysis (superiority test); GKT137831 vs Placebo; p = 1.000; ANCOVA NCT02010242 ↗

Publications

• Hu S, Lee K, He JC, Fan Y. Current Landscape and Emerging Therapeutic Targets in Diabetic Kidney Disease. Clin J Am Soc Nephrol. 2026 Mar 10. doi: 10.2215/CJN.0000001053. Online ahead of print.

Drugs

Indications