Primary objective: \- To characterize the effects of 12 weeks treatment with study drug on albumin-creatinine ratio (ACR) in patients with type 2 diabetes and albuminuria Secondary objectives: * To characterize the effect of study drug on glycosylated hemoglobin fraction (HbA1c) * To evaluate the effect of study drug on markers of glycemic disorders, systemic inflammation, renal and liver disease and cardiovascular function * To assess the safety and tolerability of study drug * To determine the population pharmacokinetics (PK) of study drug
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
76
0.5 mg/kg study drug or placebo as SC injections twice a week
Unnamed facility
Prague, Czechia
Unnamed facility
Aschaffenburg, Germany
Unnamed facility
Dortmund, Germany
Effect of NOX-E36 on albuminuria as measured by ACR (albumin to creatinine ratio; mg/g)
ACR calculated in first morning void urine; comparison of patients treated with NOX-E36 versus placebo
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on hsCRP
Comparison of patients treated with NOX-E36 versus placebo
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HbA1C
Comparison of patients treated with NOX-E36 versus placebo
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on HOMA-IR
Comparison of patients treated with NOX-E36 versus placebo
Time frame: Change versus baseline after 12 weeks treatment
Effect of NOX-E36 on eGFR
eGFR will be calculated by the CKD-EPI equation using creatinine and cystatin C Comparison of patients treated with NOX-E36 versus placebo
Time frame: Change versus baseline after 12 weeks treatment
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Unnamed facility
Düsseldorf, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Kronberg, Germany
Unnamed facility
Mainz, Germany
Unnamed facility
Mannheim, Germany
Unnamed facility
Offenbach, Germany
Unnamed facility
Schwabenheim, Germany
...and 14 more locations