Status:
COMPLETED
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
Juvenile Diabetes Research Foundation
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
12-45 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo infusion. Insulin secretion will be ass...
Detailed Description
The following visits are required: * Screening Visits: 2 to 3 appointments will be conducted to determine eligibility. At 2 of these visits participants will drink a liquid meal and have blood tests ...
Eligibility Criteria
Inclusion
- Ages 12-45
- Diagnosis of diabetes mellitus, consistent with ADA criteria
- No more than 90 days between diagnosis and administration of study compounds
- Requires insulin for type 1 diabetes mellitus, or has required insulin at some time between diagnosis and administration of study compounds.
- Stimulated C-peptide level greater than 0.20 nmol/L and less than or equal to 3.50 nmol/L
- Positive for one or more of the autoantibodies typically associated with T1DM: antibody to glutamic acid decarboxylase (anti-GAD); antibody to protein tyrosine phosphatase-like protein (anti-IA-2); zinc transporter autoantibodies (ZNT8); insulin autoantibodies (IAA). A subject who is positive for insulin autoantibodies (IAA) and negative for the other autoantibodies will only be eligible if the subject has used insulin for less than 7 days total.
Exclusion
- Other, significant medical conditions based on the study doctor's evaluation
Key Trial Info
Start Date :
July 29 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2012
Estimated Enrollment :
272 Patients enrolled
Trial Details
Trial ID
NCT00678886
Start Date
July 29 2008
End Date
January 31 2012
Last Update
October 3 2017
Active Locations (109)
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1
GSK Investigational Site
Birmingham, Alabama, United States, 35294
2
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
3
GSK Investigational Site
Costa Mesa, California, United States, 92626
4
GSK Investigational Site
Los Angeles, California, United States, 90033