Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Public ClinicalTrials.gov record NCT00678886. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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: http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD\&rank=1
Study identification
- NCT ID
- NCT00678886
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 272 participants
Conditions and interventions
Conditions
Interventions
- otelixizumab infusion plus physician determined standard of care Biological
- placebo infusion plus physician determined standard of care Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Years to 45 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2008 (Actual)
- Primary completion
- Jan 31, 2012 (Actual)
- Completion
- Jan 31, 2012 (Actual)
- Last update posted
- Oct 3, 2017
2008 – 2012
United States locations
- U.S. sites
- 67
- U.S. states
- 31
- U.S. cities
- 61
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | — |
| GSK Investigational Site | Costa Mesa | California | 92626 | — |
| GSK Investigational Site | Los Angeles | California | 90033 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | Santa Ana | California | 92705 | — |
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Walnut Creek | California | 94598 | — |
| GSK Investigational Site | Aurora | Colorado | 80045 | — |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20037 | — |
| GSK Investigational Site | Boca Raton | Florida | 33486 | — |
| GSK Investigational Site | Jupiter | Florida | 33458 | — |
| GSK Investigational Site | Miami | Florida | 33136 | — |
| GSK Investigational Site | Miami | Florida | 33169 | — |
| GSK Investigational Site | Orlando | Florida | 32803 | — |
| GSK Investigational Site | Orlando | Florida | 32835 | — |
| GSK Investigational Site | Pembroke Pines | Florida | 33024 | — |
| GSK Investigational Site | Trinity | Florida | 34655 | — |
| GSK Investigational Site | Winter Park | Florida | 32789 | — |
| GSK Investigational Site | Atlanta | Georgia | 30309 | — |
| GSK Investigational Site | Atlanta | Georgia | 30342 | — |
| GSK Investigational Site | Honolulu | Hawaii | 96813 | — |
| GSK Investigational Site | Boise | Idaho | 83702 | — |
| GSK Investigational Site | Idaho Falls | Idaho | 83404-7542 | — |
| GSK Investigational Site | Chicago | Illinois | 60612 | — |
| GSK Investigational Site | Chicago | Illinois | 60637 | — |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | — |
| GSK Investigational Site | Atlanta | Kansas | 21287 | — |
| GSK Investigational Site | Topeka | Kansas | 66606 | — |
| GSK Investigational Site | Baltimore | Maryland | 21201 | — |
| GSK Investigational Site | Worcester | Massachusetts | 01655-0002 | — |
| GSK Investigational Site | Detroit | Michigan | 48201 | — |
| GSK Investigational Site | Kalamazoo | Michigan | 49048 | — |
| GSK Investigational Site | Gulfport | Mississippi | 39501 | — |
| GSK Investigational Site | Columbia | Missouri | 65212 | — |
| GSK Investigational Site | Kansas City | Missouri | 64106 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Omaha | Nebraska | 68131 | — |
| GSK Investigational Site | Neptune City | New Jersey | 07753 | — |
| GSK Investigational Site | Buffalo | New York | 14209 | — |
| GSK Investigational Site | Mineola | New York | 11501 | — |
| GSK Investigational Site | New York | New York | 10032 | — |
| GSK Investigational Site | Rochester | New York | 14642 | — |
| GSK Investigational Site | Durham | North Carolina | 27713 | — |
| GSK Investigational Site | Columbus | Ohio | 43205 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Dayton | Ohio | 45415-2560 | — |
| GSK Investigational Site | Mentor | Ohio | 44060 | — |
| GSK Investigational Site | Tulsa | Oklahoma | 74136-8303 | — |
| GSK Investigational Site | Eugene | Oregon | 97401 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Langhorne | Pennsylvania | 19047 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | — |
| GSK Investigational Site | Charleston | South Carolina | 29425-6240 | — |
| GSK Investigational Site | Rapid City | South Dakota | 57701 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37403 | — |
| GSK Investigational Site | Memphis | Tennessee | 38119 | — |
| GSK Investigational Site | Nashville | Tennessee | 37212 | — |
| GSK Investigational Site | Dallas | Texas | 75231 | — |
| GSK Investigational Site | Dallas | Texas | 75390 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | Hurst | Texas | 76054 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Schertz | Texas | 782154 | — |
| GSK Investigational Site | Ogden | Utah | 84403 | — |
| GSK Investigational Site | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00678886, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 3, 2017 · Synced Oct 27, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00678886 live on ClinicalTrials.gov.