Phase 2
Completed N=136
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
Type 2 Diabetes Mellitus With Diabetic Nephropathy
Source: ClinicalTrials.gov NCT02010242 ↗
Enrolled (actual)
136
Serious AEs
5.9%
Results posted
Feb 2025
Primary outcomePrimary: Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group — 705.72; 696.30; 758.22; 705.29 mg/g — p=1.000
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Albuminuria Absolute Value and Ratio to Baseline by Study Visit and Treatment Group |
705.72; 696.30; 758.22; 705.29 | 1.000 |
| SECONDARY Glucose Metabolism by Homeostatic Model Assessment (HOMA) |
0.916; 2.013; 0.344; -1.833; 12.94; 50.10 | — |
| SECONDARY Glucose Metabolism HbA1c |
0.02; -0.03; 0.12; 0.03 | — |
| SECONDARY 24 Hours Albumin Excretion |
389.82; -56.15 | — |
| SECONDARY 24 Hours Urine UACR |
220.15; 169.98 | — |
| SECONDARY eGFR Change by Study Visit |
-0.5; -0.4; -0.6; -1.5; -0.1; -0.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02010242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.