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COMPLETEDPHASE2

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

NCT02010242•Calliditas Therapeutics AB

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female aged 18 to 80 years
•History of type 2 diabetes, defined as fasting plasma glucose ≥7.0 mmol/L (126 mg/dL) or a glycated hemoglobin (HbA1c) \>6.5% (48 mmol/mol) on at least 2 occasions prior to screening.
•Albuminuria defined as a UACR of 300 to 3500 mg/g.
•An eGFR ≥30 mL/min/1.73 m2, as calculated by the CKD-EPI formula.
•Must be taking an ACEI or an ARB for at least 6 weeks prior to the first screening visit (Visit 1) and during the screening period. The dose must have been stable for at least 4 weeks prior to the first screening visit (Visit 1). Combination therapy associating an ACEI and an ARB is not permitted.

Exclusion Criteria

•History of type 1 diabetes
•Any other non-diabetic kidney disease(s) except for hypertensive nephropathy which is acceptable.
•Diagnostic or interventional procedure requiring a contrast agent within 4 weeks of the first screening visit (Visit 1) or planned during the study.
•History of renal transplant or planned renal transplant during the study.
•A history of acute renal dialysis or acute kidney injury (defined according to the Kidney Disease: Improving Global Outcomes \[KDIGO\] definition) within 12 weeks of the first screening visit (Visit 1)
•HbA1c level \>11% (97 mmol/mol).
•History of hypothyroidism requiring hormone replacement therapy.
•History of active cardiovascular disease
•A personal or family history of long QT syndrome.
•Administration of any investigational product within 30 days or within 5 half-lives of the investigational agent

Locations (48)

Advanced Arizona Clinical Research

Tucson, Arizona, United States

The Endocrine Medical Group, Inc

Orange, California, United States

Clinical Research of South Florida

Coral Gables, Florida, United States

The Center for Diabetes and Endocrine Care

Hollywood, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Genoma Research Group, Inc.

Miami, Florida, United States

Coral Research Clinic

Miami, Florida, United States

Pines Clinical Research Inc.

Pembroke Pines, Florida, United States

Volunteer Medical Research

Port Charlotte, Florida, United States

John H. Stroger Jr. Hospital of Cook County

Chicago, Illinois, United States

Key Dates

Start Date

October 1, 2013

Primary Completion Date

February 1, 2015

Completion Date

March 1, 2015

Last Updated

February 28, 2025

Enrollment

136

ACTUAL participants

Conditions

Type 2 Diabetes Mellitus With Diabetic Nephropathy

Interventions

GKT137831

DRUG

Placebo

DRUG

Serum 1,25-dihydroxyvitamin D Levels in Type 2 Diabetes Mellitus Patients With Different Levels of Albuminuria

NCT01845870

Type 2 Diabetes Mellitus With Diabetic Nephropathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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