A Study of the Safety and Pharmacokinetics of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes
|ClinicalTrials.gov Identifier: NCT01427699|
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : October 31, 2012
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: T2-18C3 therapeutic antibody||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Safety, Pharmacokinetics, and Preliminary Efficacy of an Anti-Inflammatory Therapeutic Antibody (MABp1) in Patients With Type 2 Diabetes|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||October 2012|
Experimental: T2-18C3 therapeutic antibody
9 subjects will receive the T2-18C3 therapeutic antibody.
Drug: T2-18C3 therapeutic antibody
1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
- Safety and Tolerability [ Time Frame: 90 days ]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.
- Pharmacokinetics [ Time Frame: 90 days ]Serum levels of T2-18C3 will be measured in patients
- Preliminary Efficacy [ Time Frame: 90 days ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01427699
|University Hospital of Basel|
|Basel, Switzerland, CH-4031|