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

NCT02010242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2025-02-28

Study results available
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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.

Conditions

  • Type 2 Diabetes Mellitus With Diabetic Nephropathy

Interventions

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.

Sponsors & Collaborators

  • Calliditas Therapeutics AB

    lead INDUSTRY

Principal Investigators

  • Philippe Wiesel, MD · Calliditas Therapeutics AB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02010242 on ClinicalTrials.gov