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NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

NCT01085292 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2013-02-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

NOX-E36

Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d

DRUG

NOX-E36

Multiple dose of 0.0625 mg/kg, 0.125 mg/kg, 0.25 mg/kg or placebo i.v. to patients with type 2 diabetes mellitus (ratio 3:1); dosing frequency q2d

Sponsors & Collaborators

  • Profil Institut für Stoffwechselforschung GmbH

    collaborator INDUSTRY

  • TME Pharma AG

    lead INDUSTRY

Principal Investigators

  • Grit Landgraf, PhD · Noxxon AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01085292 on ClinicalTrials.gov