drugset / Trial / NCT01547897
NOX-E36 in Patients With Type 2 Diabetes Mellitus and Albuminuria
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NOX-E36 | Aptamer | 0.5 mg/kg | Subcutaneous |