drugset / Trial / NCT01547897

NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria

NCT01547897 ↗

Phase 2 Completed 76 enrolled TME Pharma AG
RandomizedParallel-groupTriple-blindTreatment

Summary

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

Timeline

Start
2012-03
Primary completion
2013-09
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator NOX-E36 Aptamer 0.5 mg/kg Subcutaneous