Trial record 1 of 38 for:
defend
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
This study has been completed.
Sponsor:
GlaxoSmithKline
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00678886
First received: May 13, 2008
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Durable-Response Therapy Evaluation ForEarly or New-Onset Type 1 Diabetes - DEFEND |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 272 |
| Study Start Date: | July 2008 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: otelixizumab
otelixizumab
|
Biological: otelixizumab infusion plus physician determined standard of care
infusion
Other Names:
|
|
Placebo Comparator: placebo
Placebo
|
Biological: placebo infusion plus physician determined standard of care
infusion
|
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 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.
Eligibility| Ages Eligible for Study: | 12 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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 Criteria:
- Other, significant medical conditions based on the study doctor's evaluation
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678886
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| United States, Alabama | |
| GSK Investigational Site | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| Costa Mesa, California, United States, 92626 | |
| GSK Investigational Site | |
| Los Angeles, California, United States, 90033 | |
| GSK Investigational Site | |
| Orange, California, United States, 92868 | |
| GSK Investigational Site | |
| Riverside, California, United States, 92506 | |
| GSK Investigational Site | |
| Santa Ana, California, United States, 92705 | |
| GSK Investigational Site | |
| Torrance, California, United States, 90502 | |
| GSK Investigational Site | |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Aurora, Colorado, United States, 80045 | |
| United States, District of Columbia | |
| GSK Investigational Site | |
| Washington, District of Columbia, United States, 20037 | |
| United States, Florida | |
| GSK Investigational Site | |
| Boca Raton, Florida, United States, 33486 | |
| GSK Investigational Site | |
| Jupiter, Florida, United States, 33458 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33169 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32835 | |
| GSK Investigational Site | |
| Orlando, Florida, United States, 32803 | |
| GSK Investigational Site | |
| Pembroke Pines, Florida, United States, 33024 | |
| GSK Investigational Site | |
| Trinity, Florida, United States, 34655 | |
| GSK Investigational Site | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30309 | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30342 | |
| United States, Hawaii | |
| GSK Investigational Site | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| GSK Investigational Site | |
| Boise, Idaho, United States, 83702 | |
| GSK Investigational Site | |
| Idaho Falls, Idaho, United States, 83404-7542 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kansas | |
| GSK Investigational Site | |
| Baltimore, Kansas, United States, 21287 | |
| GSK Investigational Site | |
| Topeka, Kansas, United States, 66606 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| Worcester, Massachusetts, United States, 01655-0002 | |
| United States, Michigan | |
| GSK Investigational Site | |
| Detroit, Michigan, United States, 48201 | |
| GSK Investigational Site | |
| Kalamazoo, Michigan, United States, 49048 | |
| United States, Mississippi | |
| GSK Investigational Site | |
| Gulfport, Mississippi, United States, 39501 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Columbia, Missouri, United States, 65212 | |
| GSK Investigational Site | |
| Kansas City, Missouri, United States, 64106 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| GSK Investigational Site | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Neptune, New Jersey, United States, 07753 | |
| United States, New York | |
| GSK Investigational Site | |
| Buffalo, New York, United States, 14209 | |
| GSK Investigational Site | |
| Mineola, New York, United States, 11501 | |
| GSK Investigational Site | |
| New York, New York, United States, 10032 | |
| GSK Investigational Site | |
| Rochester, New York, United States, 14642 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27713 | |
| United States, Ohio | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43205 | |
| GSK Investigational Site | |
| Columbus, Ohio, United States, 43210 | |
| GSK Investigational Site | |
| Dayton, Ohio, United States, 45415-2560 | |
| GSK Investigational Site | |
| Mentor, Ohio, United States, 44060 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Tulsa, Oklahoma, United States, 74136-8303 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Eugene, Oregon, United States, 97401 | |
| GSK Investigational Site | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Langhorne, Pennsylvania, United States, 19047 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29425-6240 | |
| United States, South Dakota | |
| GSK Investigational Site | |
| Rapid City, South Dakota, United States, 57701 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Chattanooga, Tennessee, United States, 37403 | |
| GSK Investigational Site | |
| Memphis, Tennessee, United States, 38119 | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37212 | |
| United States, Texas | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75390 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75231 | |
| GSK Investigational Site | |
| Houston, Texas, United States, 77030 | |
| GSK Investigational Site | |
| Hurst, Texas, United States, 76054 | |
| GSK Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
| GSK Investigational Site | |
| Schertz, Texas, United States, 782154 | |
| United States, Utah | |
| GSK Investigational Site | |
| Ogden, Utah, United States, 84403 | |
| United States, Washington | |
| GSK Investigational Site | |
| Tacoma, Washington, United States, 98405 | |
| Canada, Alberta | |
| GSK Investigational Site | |
| Calgary, Alberta, Canada, T2H 2G4 | |
| Canada, Ontario | |
| GSK Investigational Site | |
| Oakville, Ontario, Canada, L6H 3P1 | |
| GSK Investigational Site | |
| Smith Falls, Ontario, Canada, K7A 4W8 | |
| GSK Investigational Site | |
| Toronto, Ontario, Canada, M4G 3E8 | |
| Canada, Quebec | |
| GSK Investigational Site | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| GSK Investigational Site | |
| Pointe-Claire, Quebec, Canada, H9R 3J1 | |
| Denmark | |
| GSK Investigational Site | |
| Arhus C, Denmark, 8000 | |
| Finland | |
| GSK Investigational Site | |
| Tampere, Finland, 33520 | |
| GSK Investigational Site | |
| Turku, Finland, 20520 | |
| Germany | |
| GSK Investigational Site | |
| Heidelberg, Baden-Wuerttemberg, Germany, 69120 | |
| GSK Investigational Site | |
| Bad Nauheim, Hessen, Germany, 61231 | |
| GSK Investigational Site | |
| Bad Lauterberg, Niedersachsen, Germany, 37431 | |
| GSK Investigational Site | |
| Berlin, Germany, 12200 | |
| Italy | |
| GSK Investigational Site | |
| Latina, Lazio, Italy, 04100 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00161 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00157 | |
| GSK Investigational Site | |
| Roma, Lazio, Italy, 00168 | |
| GSK Investigational Site | |
| Monserrato, Sardegna, Italy, 09042 | |
| GSK Investigational Site | |
| Palermo, Sicilia, Italy, 90127 | |
| GSK Investigational Site | |
| Milano, Italy, 20132 | |
| GSK Investigational Site | |
| Roma, Italy, 00128 | |
| Spain | |
| GSK Investigational Site | |
| Barcelona, Spain, 8035 | |
| GSK Investigational Site | |
| Gerona, Spain | |
| GSK Investigational Site | |
| Madrid, Spain, 28040 | |
| GSK Investigational Site | |
| Sant Joan, Spain, ´03550 | |
| GSK Investigational Site | |
| Tarrasa, Barcelona, Spain, 08221 | |
| Sweden | |
| GSK Investigational Site | |
| Göteborg, Sweden, SE-413 45 | |
| GSK Investigational Site | |
| Halmstad, Sweden, SE-301 85 | |
| GSK Investigational Site | |
| Harnosand, Sweden, 871 82 | |
| GSK Investigational Site | |
| Karlskrona, Sweden, SE- 371 85 | |
| GSK Investigational Site | |
| Karlstad, Sweden, SE-651 85 | |
| GSK Investigational Site | |
| Kristianstad, Sweden, 291 85 | |
| GSK Investigational Site | |
| Motala, Sweden, SE-591 85 | |
| GSK Investigational Site | |
| Stockholm, Sweden, SE-171 76 | |
| GSK Investigational Site | |
| Umeå, Sweden, SE-901 85 | |
| GSK Investigational Site | |
| Växjö, Sweden, SE-351 85 | |
| United Kingdom | |
| GSK Investigational Site | |
| Bath, Somerset, United Kingdom, BA1 3NG | |
| GSK Investigational Site | |
| Blackburn, United Kingdom, BB2 3HH | |
| GSK Investigational Site | |
| Bristol, United Kingdom, BS2 8HW | |
| GSK Investigational Site | |
| Hull, United Kingdom, HU3 2RW | |
| GSK Investigational Site | |
| London, United Kingdom, SE1 9RT | |
| GSK Investigational Site | |
| Newcastle upon Tyne, United Kingdom, NE1 4LP | |
Sponsors and Collaborators
GlaxoSmithKline
Juvenile Diabetes Research Foundation
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
Additional Information:
Publications:
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00678886 History of Changes |
| Obsolete Identifiers: | NCT00893022 |
| Other Study ID Numbers: | 115495, TRX4006 |
| Study First Received: | May 13, 2008 |
| Last Updated: | February 7, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency Italy: Ministry of Health Canada: Health Canada Denmark: Danish Medicines Agency Germany: Paul-Ehrlich-Institut Sweden: Medical Products Agency Spain: Spanish Agency for Medicines and Health Products United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Type 1 diabetes new onset type 1 diabetes T1DM Type l diabetes juvenile diabetes |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 17, 2013