NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of this trial is to evaluate the safety and tolerability of multiple
intravenous doses of NOX-E36 in healthy subjects and patients with type 2 diabetes mellitus.
A secondary objective of the trial is to obtain exploratory estimates of the pharmacodynamic
response at the level of inflammation, metabolism as well as ongoing diabetes complications
(e.g. impaired cardiovascular, liver and renal function). Thus, the study is designed to
provide sufficient safety and dose-response data for a planned Phase IIa proof of concept
study with NOX-E36 in patients with multiple complications of type II diabetes mellitus.