Conditions: Type 2 Diabetes Mellitus With Diabetic Nephropathy
Keywords: Type 2 diabetes Proteinuria Albuminuria
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 136
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: GKT137831 100 mg capsules twice a day arm 2: Placebo capsule twice a day

Interventions: intervention 1: GKT137831 intervention 2: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.

Protocol document: