Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1

This study has been completed.
Sponsor:
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
  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:
  • monoclonal antibody
  • ChAglyCD3
  • anti-CD3
  • TRX4
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00678886

  Hide Study Locations
Locations
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
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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
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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
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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
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Dallas, Texas, United States, 75390
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Dallas, Texas, United States, 75231
GSK Investigational Site
Houston, Texas, United States, 77030
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Hurst, Texas, United States, 76054
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San Antonio, Texas, United States, 78229
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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
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Smith Falls, Ontario, Canada, K7A 4W8
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Toronto, Ontario, Canada, M4G 3E8
Canada, Quebec
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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
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Motala, Sweden, SE-591 85
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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
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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

ClinicalTrials.gov processed this record on September 18, 2014