Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1 (DEFEND-1)
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 assessed using mixed meal-stimulated C-peptide.
Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other physician determined standard of care treatments.
DEFEND-1 is now closed to enrollment.
DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require subjects with new onset type 1 diabetes. Please check back here for more details.
In the meantime, established and new onset type 1 diabetes patients in North America are welcome to consider the TTEDD study:
|Diabetes Mellitus, Type 1||Biological: otelixizumab infusion plus physician determined standard of care Biological: placebo infusion plus physician determined standard of care||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND|
- Amount of C-peptide (a protein that shows how much insulin the body is producing) during a mixed meal stimulation test. [ Time Frame: at 12 months ]
- Average daily insulin use, HbA1c (a measurement of blood glucose control), and incidence of abnormal blood glucose levels. [ Time Frame: at Months 6, 12, 18, and 24 ]
|Study Start Date:||July 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Biological: otelixizumab infusion plus physician determined standard of care
Placebo Comparator: placebo
Biological: placebo infusion plus physician determined standard of care
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 done over the post-meal period.
- Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 4-6 hours.
- Follow-up Visits: weekly for the first month, then every 2 weeks for 3 months, followed by monthly visits through 1 year. There will be 3 visits in the second year.
- The total duration of the study is 2 years.
- Glucose test strips, glucose monitors and PDAs to record insulin will be provided to all study subjects for the duration fo the study. Frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678886
Show 109 Study Locations
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|