Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2

This study has been completed.
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01123083
First received: May 11, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

DEFEND-2 is a Phase 3 confirmatory study for the Phase 3 DEFEND-1 study. The study objective is 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.


Condition Intervention Phase
Diabetes Mellitus, Type 1
Biological: Otelixizumab
Biological: Placebo
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: DEFEND 2: Durable-Response Therapy Evaluation ForEarly- or New-Onset Type 1 Diabetes

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 Week 12, Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]

Enrollment: 179
Study Start Date: May 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: otelixizumab
otelixizumab
Biological: Otelixizumab
infusion
Other Names:
  • ChAglyCD3
  • TRX4
  • monoclonal antibody
  • anti-CD3
Placebo Comparator: placebo
placebo
Biological: Placebo
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. Participants will also be required to wear a continuous glucose monitor for a short period of time.
  • Dosing Visits: 8 outpatient visits on consecutive days, each lasting about 2-4 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 and glucose monitors will be provided to participants for the duration of the study. Frequent glycemic monitoring will occur through lab testing and blood glucose self-monitoring to help facilitate tight glycemic control in all subjects. Subjects will be asked to intermittently record their insulin doses using a telephone or web based system and continuous glucose monitoring will be performed every 6 months.
  Eligibility

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ages 12-17
  • 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. In Canada, has to be using insulin at the time of dosing.
  • 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: NCT01123083

  Hide Study Locations
Locations
United States, California
GSK Investigational Site
Huntington Beach, California, United States, 92648
GSK Investigational Site
Los Angeles, California, United States, 90015
GSK Investigational Site
Orange, California, United States, 92868
GSK Investigational Site
San Diego, California, United States, 92103
GSK Investigational Site
Tarzana, California, United States, 91356
GSK Investigational Site
Torrance, California, United States, 90509
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
Boynton Beach, Florida, United States, 33435
GSK Investigational Site
Miami, Florida, United States, 33175
GSK Investigational Site
Orlando, Florida, United States, 32803
GSK Investigational Site
Orlando, Florida, United States, 32835
GSK Investigational Site
Wellington, Florida, United States, 33414
United States, Georgia
GSK Investigational Site
Atlanta, Georgia, United States, 30322
GSK Investigational Site
Atlanta, Georgia, United States, 30309
GSK Investigational Site
Atlanta, Georgia, United States, 30342
United States, Idaho
GSK Investigational Site
Boise, Idaho, United States, 83702
GSK Investigational Site
Idaho Falls, Idaho, United States, 83404
United States, Illinois
GSK Investigational Site
Chicago, Illinois, United States, 60612
United States, Indiana
GSK Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kansas
GSK Investigational Site
Kansas City, Kansas, United States, 66160
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21204
United States, Michigan
GSK Investigational Site
Kalamazoo, Michigan, United States, 49048
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
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, New York
GSK Investigational Site
New York, New York, United States, 10032
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27713
GSK Investigational Site
Raleigh, North Carolina, United States, 27610
United States, Ohio
GSK Investigational Site
Columbus, Ohio, United States, 43201
GSK Investigational Site
Columbus, Ohio, United States, 43210
GSK Investigational Site
Mentor, Ohio, United States, 44060
United States, Oregon
GSK Investigational Site
Eugene, Oregon, United States, 97401
United States, South Dakota
GSK Investigational Site
Rapid City, South Dakota, United States, 57701
United States, Tennessee
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Kingsport, Tennessee, United States, 37660
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Memphis, Tennessee, United States, 38103
GSK Investigational Site
Nashville, Tennessee, United States, 37212
United States, Texas
GSK Investigational Site
Dallas, Texas, United States, 75231
GSK Investigational Site
Houston, Texas, United States, 77022
GSK Investigational Site
San Antonio, Texas, United States, 78222
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84403
United States, Virginia
GSK Investigational Site
Richmond, Virginia, United States, 23298
Belgium
GSK Investigational Site
Brussels, Belgium, 1090
GSK Investigational Site
Bruxelles, Belgium, 1020
GSK Investigational Site
Edegem, Belgium, 2650
GSK Investigational Site
Gent, Belgium, 9000
GSK Investigational Site
Leuven, Belgium, 3000
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
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Cambridge, Ontario, Canada, N1R 7L6
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Oakville, Ontario, Canada, L6H 3P1
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Smith Falls, Ontario, Canada, K7A 4W8
GSK Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Denmark
GSK Investigational Site
Arhus C, Denmark, 8000
GSK Investigational Site
Esbjerg, Denmark, 6700
Finland
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Tampere, Finland, 33520
GSK Investigational Site
Turku, Finland, 20520
Germany
GSK Investigational Site
Muenchen, Bayern, Germany, 80804
GSK Investigational Site
Bad Nauheim, Hessen, Germany, 61231
GSK Investigational Site
Bad Lauterberg, Niedersachsen, Germany, 37431
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30173
GSK Investigational Site
Duesseldorf, Nordrhein-Westfalen, Germany, 40225
GSK Investigational Site
Muenster, Nordrhein-Westfalen, Germany, 48145
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Berlin, Germany, 12200
GSK Investigational Site
Berlin, Germany, 10409
GSK Investigational Site
Berlin, Germany, 13353
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, 00165
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Palermo, Sicilia, Italy, 90127
GSK Investigational Site
Firenze, Italy, 50139
GSK Investigational Site
Milano, Italy, 20132
GSK Investigational Site
Roma, Italy, 00155
Netherlands
GSK Investigational Site
Amersfoort, Netherlands, 3816 CP
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
GSK Investigational Site
Rotterdam, Netherlands, 3011 TG
Spain
GSK Investigational Site
Alcala de Henares, Spain, 28805
GSK Investigational Site
Almeria, Spain, 4001
GSK Investigational Site
Barcelona, Spain, 8035
GSK Investigational Site
Girona, Spain, 17007
GSK Investigational Site
Madrid, Spain, 28040
GSK Investigational Site
Majadahonda (Madrid), Spain, 28222
GSK Investigational Site
Málaga, Spain, 29010
GSK Investigational Site
Palma de Mallorca, Spain, 07198
GSK Investigational Site
Pontevedra, Spain, 36071
GSK Investigational Site
Sabadell (Barcelona), Spain, 08208
GSK Investigational Site
Sant Joan, Spain, ´03550
GSK Investigational Site
Santa Cruz De Tenerife, Spain, 38003
GSK Investigational Site
Sevilla, Spain, 41003
GSK Investigational Site
Tarrasa, Barcelona, Spain, 08221
Sweden
GSK Investigational Site
Göteborg, Sweden, SE-413 45
GSK Investigational Site
Helsingborg, Sweden, SE-251 87
GSK Investigational Site
Härnösand, Sweden, SE-871 82
GSK Investigational Site
Karlstad, Sweden, SE-651 85
GSK Investigational Site
Kristianstad, Sweden, 291 85
GSK Investigational Site
Linköping, Sweden, SE-581 85
GSK Investigational Site
Lund, Sweden, SE-221 85
GSK Investigational Site
Motala, Sweden, 591 85
GSK Investigational Site
Stockholm, Sweden, SE-171 76
GSK Investigational Site
Trollhättan, Sweden, SE-46185
GSK Investigational Site
Umeå, Sweden, SE-901 85
GSK Investigational Site
Växjö, Sweden, SE-351 85
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
GSK Investigational Site
Bath, Somerset, United Kingdom, BA1 3NG
GSK Investigational Site
Ashton under Lyne, United Kingdom, OL6 9RW
GSK Investigational Site
Birmingham, United Kingdom, B9 5SS
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Bournemouth, United Kingdom, BH7 7DW
GSK Investigational Site
Bristol, United Kingdom, BS2 8HW
GSK Investigational Site
Cambridge, United Kingdom, CB2 0QQ
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Cardiff, United Kingdom, CF14 4XN
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
GSK Investigational Site
Hull, United Kingdom, HU3 2RW
GSK Investigational Site
Leeds, United Kingdom, LS9 7TF
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: NCT01123083     History of Changes
Other Study ID Numbers: 115494, TRX4018
Study First Received: May 11, 2010
Last Updated: December 13, 2012
Health Authority: Netherlands: Central Committee on Research inv. Human Subjects
Spain: Spanish Medicines and Health product Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Finland: Finnish Medicines Agency
Belgium: Belgian Federal Agency for Medicinal and Health Products
Italy: Ministry of Health
Canada: Health Canada
Denmark: Danish Medicines Agency
Germany: Paul-Ehrlich-Institut
Sweden: Medical Products Agency
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
new onset type 1 diabetes
juvenile diabetes
T1DM
Type 1 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