NCT02010242

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Calliditas Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus With Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	GKT137831	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
DRUG	Placebo	1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.

Timeline

• Start date: 2013-10-01
• Primary completion: 2015-02-01
• Completion: 2015-03-01
• First posted: 2013-12-12
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

48 sites across 6 countries: United States, Australia, Canada, Czechia, Germany, Poland