At a glance
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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
In Brief
A Phase 2 clinical trial evaluating GKT137831 and Placebo for Type 2 Diabetes Mellitus With Diabetic Nephropathy. Completed, enrolled 136 participants across 48 sites in 6 countries.
Detailed 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.
Study Details
Timeline
Interventions
1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.