| Trial ID: | L2639 |
| Source ID: | NCT01085292
|
| Associated Drug: |
Nox-E36
|
| Title: |
NOX-E36 Multiple Ascending Dose Study in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: NOX-E36|DRUG: NOX-E36
|
| Outcome Measures: |
Primary: Safety and tolerability of multiple intravenous doses of NOX-E36 in healthy subjects and patients with type II diabetes mellitus, 4 weeks | Secondary: Multiple dose pharmacokinetics and pharmacodynamics of NOX-E36 in healthy subjects and patients with type II diabetes mellitus, 4 weeks
|
| Sponsor/Collaborators: |
Sponsor: TME Pharma AG | Collaborators: Profil Institut für Stoffwechselforschung GmbH
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
47
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: FACTORIAL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2010-07
|
| Completion Date: |
2012-02
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-13
|
| Locations: |
CTC North MediGate GmbH, Hamburg, 20246, Germany|Medizinische Hochschule Hannover, Hannover, 30625, Germany|Itecra GmbH, Köln, 50931, Germany|ikfe GmbH, Mainz, 55116, Germany|Profil Institut fuer Stoffwechselforschung GmbH, Neuss, D-41460, Germany
|
| URL: |
https://clinicaltrials.gov/show/NCT01085292
|