| Trial ID: | L5310 |
| Source ID: | NCT01427699
|
| Associated Drug: |
T2-18c3 Therapeutic Antibody
|
| Title: |
A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: T2-18C3 therapeutic antibody
|
| Outcome Measures: |
Primary: Safety and Tolerability, The safety and tolerability of T2-18C3 will be determined by observing patients for clinical adverse events, changes in vital signs, and changes in laboratory parameters such as hematology and chemistry., 90 days | Secondary: Pharmacokinetics, Serum levels of T2-18C3 will be measured in patients, 90 days|Preliminary Efficacy, The ability of T2-18C3 to improve glycemic control will be measured by comparing the change in glycosylated hemoglobin levels of patients from baseline to day 90., 90 days
|
| Sponsor/Collaborators: |
Sponsor: Janssen Research & Development, LLC
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
7
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2011-06-30
|
| Completion Date: |
|
| Results First Posted: |
|
| Last Update Posted: |
2021-02-21
|
| Locations: |
University Hospital of Basel, Basel, CH-4031, Switzerland
|
| URL: |
https://clinicaltrials.gov/show/NCT01427699
|
