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| Sponsor: | Tolerx Inc. |
|---|---|
| Collaborator: |
Juvenile Diabetes Research Foundation |
| Information provided by: | Tolerx Inc. |
| ClinicalTrials.gov Identifier: | NCT00678886 |
Purpose
To find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. 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 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
| Condition | Intervention | Phase |
|---|---|---|
|
Type 1 Diabetes Mellitus |
Biological: otelixizumab Biological: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND |
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2008 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
otelixizumab
|
Biological: otelixizumab
infusion
|
| 2: Placebo Comparator |
Biological: placebo
infusion
|
The following visits are required:
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| Univ. of Alabama at Birmingham School of Medicine (recruiting ages 12-45) | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| Little Rock Diagnostic Clinic (recruiting ages 18-45) | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Diablo Clinical Research (recruiting ages 12-45) | |
| Walnut Creek, California, United States, 94598 | |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (recruiting ages 12-45) | |
| Torrance, California, United States, 90502 | |
| Clinical Innovations, Inc. (recruiting ages 12-45) | |
| Riverside, California, United States, 92506 | |
| Clinical Innovations, Inc. (recruiting ages 18-45) | |
| Santa Ana, California, United States, 92705 | |
| Clinical Innovations, Inc. (recruiting ages 18-45) | |
| Costa Mesa, California, United States, 92626 | |
| St. Joseph Hospital (recruiting ages 18-45) | |
| Orange, California, United States, 92868 | |
| Children's Hospital of Orange County (recruiting 12-17) | |
| Orange, California, United States, 92868 | |
| SunRise Clinical Research | |
| Bell Gardens, California, United States, 90201 | |
| United States, Colorado | |
| Barbara Davis Center for Childhood Diabetes/ University of Colorado Health Sciences Center (recruiting ages 12-45) | |
| Aurora, Colorado, United States, 80015 | |
| United States, District of Columbia | |
| George Washington University (recruiting ages 12-45) | |
| Washington, D.c., District of Columbia, United States, 20037 | |
| United States, Florida | |
| Elite Research Institute (recruiting ages 18-45) | |
| Miami, Florida, United States, 33169 | |
| Advanced Diabetes Treatment Centers/ Clinical Trials Management, LLC (recruiting ages 12-45) | |
| Orlando, Florida, United States, 32803 | |
| Advanced Diabetes Treatment Centers/ Clinical Trials Management, LLC (recruiting ages 18-45) | |
| Boca Raton, Florida, United States, 33486 | |
| Orlando Diabetes and Endocrine Specialists (recruiting ages 17-45) | |
| Orlando, Florida, United States, 32835 | |
| Advanced Research Institute, Inc. (recruiting ages 18-45) | |
| Trinity, Florida, United States, 34655 | |
| Advanced Pharma Clinical Research | |
| Miami, Florida, United States, 33142 | |
| United States, Georgia | |
| Laureate Clinical Medical Research (recruiting ages 12-45) | |
| Atlanta, Georgia, United States, 30342 | |
| Atlanta Diabetes Associates (recruiting ages 12-45) | |
| Atlanta, Georgia, United States, 30309 | |
| United States, Hawaii | |
| Hawaii Clinical Research Center (recruiting ages 18-45) | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Rocky Mountrain Diabetes and Osteoporosis Center (recruiting ages 12-45) | |
| Idaho Falls, Idaho, United States, 83404 | |
| Humphrey Diabetes Center (recruiting ages 12-45) | |
| Boise, Idaho, United States, 83702 | |
| United States, Illinois | |
| University of Chicago (recruiting ages 12-45) | |
| Chicago, Illinois, United States, 60637 | |
| John H. Stroger Jr. Hospital of Cook Country (recruiting ages 18-45) | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kansas | |
| Cotton-O'Neil Diabetes and Endocrinology Center (recruiting ages 12-45) | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| University of Maryland School of Medicine/Joslin Diabetes Center (recruiting ages 12-45) | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| University of Massachusetts, Memorial Hospital (recruiting ages 12-45) | |
| Worcester, Massachusetts, United States, 01655 | |
| United States, Michigan | |
| Borgess Research Institute (recruiting ages 12-45) | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Mississippi | |
| Gulfside Clinical Research, LLC (recruiting ages 12-45) | |
| Gulfport, Mississippi, United States, 39501 | |
| United States, Missouri | |
| Washington University School of Medicine (recruiting ages 16-45) | |
| St. Louis, Missouri, United States, 63110 | |
| University of Missouri (recruiting ages 12-45) | |
| Columbia, Missouri, United States, 65212 | |
| Kansas City University of Medicine and Biosciences (recruiting ages 18-45) | |
| Kansas City, Missouri, United States, 64106 | |
| United States, Nebraska | |
| Creighton University Medical Center (recruiting ages 12-45) | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Meridian Medical Associates (recruiting ages 12-45) | |
| Neptune, New Jersey, United States, 07753 | |
| United States, New York | |
| The University of Rochester Medical Center (recruiting ages 18-45) | |
| Rochester, New York, United States, 14627 | |
| State University of New York at Buffalo and Kaleida Health/Diabetes Center of WNY (recruiting ages 18-45) | |
| Buffalo, New York, United States, 14209 | |
| Winthrop University Hospital (recruiting ages 18-45) | |
| Mineola, New York, United States, 11501 | |
| Columbia University Medical Center/ Naomi Berrie Diabetes Center (recruiting ages 12-45) | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| University of North Carolina Diabetes Center (recruiting ages 18-45) | |
| Durham, North Carolina, United States, 27713 | |
| United States, Ohio | |
| Dayton Science Institute, LLC (recruiting ages 12-45) | |
| Dayton, Ohio, United States, 45419 | |
| Your Diabetes Endocrine Nutrition Group, LLC/ Clinical Research Department (recruiting ages 12-45) | |
| Mentor, Ohio, United States, 44060 | |
| The Ohio State University (recruiting ages 12-45) | |
| Columbus, Ohio, United States, 43201 | |
| Nationwide Childresn's Hospital | |
| Columbus, Ohio, United States, 43205 | |
| United States, Oklahoma | |
| Vital Prospects Clinical Research Institute, PC (recruiting ages 14-45) | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Clinical Trials of America, Inc. (recruiting ages 12-45) | |
| Eugene, Oregon, United States, 97401 | |
| Portland Diabetes & Endocrinology Center P.C. (Recruting ages 18-45) | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| St. Mary Medical Center (recruiting ages 18-45) | |
| Langhorne, Pennsylvania, United States, 19047 | |
| Temple University Hospital (recruiting ages 18-45) | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, South Carolina | |
| Medical University of South Carolina (recruiting ages 18-45) | |
| Charleston, South Carolina, United States, 29425 | |
| United States, South Dakota | |
| Dakota Regional Medical Clinic (recruiting ages 12-45) | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| Ramesh C. Gupta, MD (recruiting ages 16-45) | |
| Memphis, Tennessee, United States, 38119 | |
| University Diabetes and Endocrine Consultants (recruiting ages 12-45) | |
| Chattanooga, Tennessee, United States, 37403 | |
| Vanderbilt Diabetes Research and Training Center (recruiting ages 18-45) | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| Diabetes and Glandular Disease Clinic (recruiting ages 12 - 45) | |
| San Antonio, Texas, United States, 78229 | |
| InVision Consultants, LLC (recruiting ages 12-45) | |
| San Antonio, Texas, United States, 78217 | |
| Potenium Clinical Research (recruiting ages 15-45) | |
| Hurst, Texas, United States, 76304 | |
| Baylor College of Medicine (recruiting ages 12-45) | |
| Houston, Texas, United States, 77030 | |
| UT Southwestern Medical Center - Dallas (recruiting ages 14-45) | |
| Dallas, Texas, United States, 75390-8858 | |
| Research Institute of Dallas (recruiting ages 12-45) | |
| Dallas, Texas, United States, 75231 | |
| United States, Utah | |
| Endocrine Research Specialists (recruiting ages 12-45) | |
| Ogden, Utah, United States, 84403 | |
| United States, Washington | |
| Liberty Research Center (recruiting ages 12-45) | |
| Tacoma, Washington, United States, 98405 | |
| Canada, Ontario | |
| LMC Endocrinology Centres Ltd. (recruiting ages 18-45) | |
| Toronto, Ontario, Canada, M4R 2G4 | |
| LMC Endocrinology Centres Ltd. (recruiting ages 18-45) | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| Canadian Centre for Research on Diabetes (recruiting ages 18-45) | |
| Smith Falls, Ontario, Canada, K7A4W8 | |
| Canada, Quebec | |
| Dynamik Research, Inc (recruiting ages 18-45) | |
| Pointe-Claire, Quebec, Canada, H9R 3J1 | |
| Denmark | |
| Århus Sygehus (recruiting ages 18-35) | |
| Århus C, Denmark, 8000 | |
| Hospital of Soutwest Denmark (recruiting ages 18-35) | |
| Esbjerg, Denmark, 6700 | |
| Finland | |
| ODL Terveys OY (recruiting ages 18-35) | |
| Oulu, Finland, 90100 | |
| Tampereen Yliopistollinen Sairaala (recruiting ages 18-35) | |
| Tampere, Finland, 33520 | |
| Satakunnan Keskussairaala (recruiting ages 18-35) | |
| Pori, Finland, 28500 | |
| Kuopion Yliopistollinen Sairaala (recruiting ages 18-35) | |
| Kuopio, Finland, 70210 | |
| Turku University Hospital (recruiting ages 18-35) | |
| Turku, Finland, 20502 | |
| Åland Central Hospital (recruiting ages 18-35) | |
| Mariehamn, Finland, 22111 | |
| Germany | |
| Universitätsklinikum Dresden (recruiting ages 18-35) | |
| Dresden, Germany, 01307 | |
| Universitätsklinikum Heidelberg (recruiting ages 18-35) | |
| Heidelberg, Germany, 69120 | |
| Diabeteszentrum Bad Lauterberg (recruiting ages 18-35) | |
| Bad Lauterberg, Germany, 37431 | |
| Charite Klinikum Benjamin Franklin (recruiting ages 18-35) | |
| Berlin, Germany, 12200 | |
| Diabetes-Klinik Bad Nauheim GmbH (recruiting ages 18-35) | |
| Bad Nauheim, Germany, 61231 | |
| Klinikum Innenstadt der Ludwig-Maximilians-Universität München Studienambulanz (recruiting ages 18-35) | |
| München, Germany, 80336 | |
| Deutsches Diabetes Zentrum (recruiting ages 18-35) | |
| Düsseldorf, Germany, 40225 | |
| Italy | |
| Università Cattolica del Sacro Cuore (recruiting ages 18-35) | |
| Roma, Italy, 00168 | |
| Instituto Scientifico San Raffaele (recruiting ages 18-35) | |
| Milano, Italy, 20132 | |
| Ospedale S. Maria Goretti Polo Pontino dell'Università La Sapienza di Roma (recruiting ages 18-35) | |
| Latina, Italy, 04100 | |
| Università Campus Bio-Medico di Roma (recruiting ages 12-45) | |
| Rome, Italy, 00128 | |
| Policlinico P. Giaccone (recruiting ages 18-35) | |
| Palermo, Italy, 90127 | |
| Università La Sapienza di Roma (recruiting ages 18-35) | |
| Roma, Italy, 00198 | |
| Ospedale Sandro Pertini (recruiting ages 18-35) | |
| Rome, Italy, 00157 | |
| Italy, Sardinia | |
| Universitaria di Cagliari Polo Monserrato (recruiting ages 18-35) | |
| Monserrato (Cagliari), Sardinia, Italy, 09042 | |
| Spain | |
| Hospital Clínico San Carlos (recruiting ages 18-35) | |
| Madrid, Spain, 28040 | |
| Hospital Vall Hebrón (recruiting ages 18-35) | |
| Barcelona, Spain, 08035 | |
| Hospital Dr. Peset (recruiting ages 18-35) | |
| Valencia, Spain, 46017 | |
| Complejo Hospitalario de Pontevedra Hospital de Montecelo (recruiting ages 18-35) | |
| Pontevedra, Spain, 36071 | |
| Hospital Universitario Puerta de Hierro (recruiting ages 18-35) | |
| Madrid, Spain, 28220 | |
| Hospital Dr. Josep Trueta (recruiting ages 18-35) | |
| Girona, Spain, 17007 | |
| Hospital Mutua de Terrassa (recruiting ages 18-35) | |
| Terrassa, Spain, 08221 | |
| Fundación Jiménez-Díaz (recruiting ages 18-35) | |
| Madrid, Spain, 28040 | |
| Hospital Son Llatzer (recruiting ages 18-35) | |
| Palma de Mallorca, Spain, 07198 | |
| Hospital Universitario Sant Joan (recruiting ages 18-35) | |
| Sant Joan Alicante, Spain, 03550 | |
| Sweden | |
| Karolinska Universitetssjukhuset (recruiting ages 18-45) | |
| Stockholm, Sweden, 171 76 | |
| Forskningsenheten, Centralsjukhuset I Kristianstad (recruiting ages 18-45) | |
| Kristianstad, Sweden, 291 85 | |
| Norrlands Universitetssjukhus (recruiting ages 18-45) | |
| Umea, Sweden, 901 85 | |
| Länssjukhuset Halmstad (recruiting ages 18-45) | |
| Halmstad, Sweden, 301 85 | |
| Blekingesjukhuset (recruiting ages 18-45) | |
| Karlskrona, Sweden, 371 85 | |
| Kärnsjukhuset i Skövde (recruiting ages 18-45) | |
| Skövde, Sweden, 541 85 | |
| Centrallasarettet Medicin och Endokrinologmottagningen (recruiting ages 18-45) | |
| Växjö, Sweden, 351 85 | |
| Alingsås Lasarett Diabetesmottagningen (recruiting ages 18-45) | |
| Alingsås, Sweden, 441 83 | |
| Centralsjuhuset Karlstad (recruiting ages 18-45) | |
| Karlstad, Sweden, 651 85 | |
| Oskarshamns Sjukhus Metabolenheten (recruiting ages 18-45) | |
| Oskarshamn, Sweden, 572 28 | |
| Köpings Lasarett (recruiting ages 18-45) | |
| Köping, Sweden, 731 81 | |
| NSV Lasarettet Motala (recruiting ages 18-45) | |
| Motala, Sweden, 591 85 | |
| Härnösands Sjukhus Öbackakliniken (recruiting ages 18-45) | |
| Harnosand, Sweden, 871 82 | |
| Lundberg Laboratorium for Diabetic Research/SU Sahlgrenska Sjukhuset (recruiting ages 18-45) | |
| Gothenburg, Sweden, 413 45 | |
| United Kingdom | |
| Bristol Royal Infirmary (recruiting ages 18-35) | |
| Bristol, United Kingdom, BS2 8HW | |
| Royal Blackburn Hospital (recruiting ages 18-35) | |
| Blackburn, United Kingdom, BB2 3HH | |
| Newcastle Clinical Research Facility (recruiting ages 18-35) | |
| Newcastle Upon Tyne, United Kingdom, NE1 4LP | |
| Michael White Diabetes Centre (recruiting ages 18-35) | |
| Hull, United Kingdom, HU3 2RW | |
| Royal United Hospital (recruiting ages 18-35) | |
| Bath, United Kingdom, BA1 3NG | |
| Guy's Hospital (recruiting ages 18-35) | |
| London, United Kingdom, SE1 9RT | |
| Lincoln House, Heart of England NHS Trust, Heartlands Hospital (recruiting ages 18-35) | |
| Birmingham, United Kingdom, B9 5SS | |
| Wolfson Clinic Institute of Metabolic Science Addenbrookes Hospital (recruiting ages 18-35) | |
| Cambridge, United Kingdom, CB2 2QQ | |
| United Kingdom, Scotland | |
| Royal Infirmary of Edinburgh (recruiting ages 18-35) | |
| Edinburgh, Scotland, United Kingdom, EH16 4SA | |
| Raigmore Hospital (recruiting ages 18-35) | |
| Inverness, Scotland, United Kingdom, IV2 3JH | |
More Information
| Responsible Party: | Tolerx, Inc. ( Kathleen Osborn/Clinical Study Manager ) |
| Study ID Numbers: | TRX4006 |
| Study First Received: | May 13, 2008 |
| Last Updated: | December 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00678886 History of Changes |
| Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Denmark: Danish Medicines Agency; Finland: Finnish Medicines Agency; Germany: Paul-Ehrlich-Institut; Italy: Ministry of Health; Spain: Spanish Medicines and Health product Agency; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
|
Type 1 diabetes new onset type 1 diabetes juvenile diabetes T1DM Type l diabetes |
|
Antibodies, Monoclonal Autoimmune Diseases Metabolic Diseases Immunologic Factors Immune System Diseases Diabetes Mellitus, Type 1 |
Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |
