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

Calliditas Therapeutics

Status and phase

Completed

Phase 2

Conditions

Type 2 Diabetes Mellitus With Diabetic Nephropathy

Treatments

Drug: GKT137831

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02010242

GSN000200

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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