Phase 2
N=136
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
Type 2 Diabetes Mellitus With Diabetic Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT02010242 ↗Enrolled (actual)
136
Serious AEs
5.9%
Results posted
Feb 2025
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GKT137831 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Calliditas Therapeutics AB
- Primary completion
- Feb 2015
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 | — |
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.
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.