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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678886
First Posted: May 16, 2008
Last Update Posted: October 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
GlaxoSmithKline
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change From Baseline in 2-hour Mixed Meal Stimulated C-peptide Area Under Curve [AUC] (Normalized for 120-minute Time Interval) at Month 12 [ Time Frame: Baseline (0-120 minutes on Day 1) and Month 12 (0-120 minutes) ]
    Mixed meal-stimulated C-peptide AUC was the area under the C-peptide/time curve from Time 0 to 120 minutes, calculated using the trapezoidal rule. This reported AUC was normalized for time interval by dividing it by 120 minutes. This normalized AUC was calculated for each participant at Baseline, Week 12, and at Months 6, 12, 18, and 24. Data has been presented for meal stimulated C-peptide Area under assessment performed at Month 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Month 12.


Secondary Outcome Measures:
  • Number of Participants Who Were Responders for (Glycosylated Hemoglobin) HbA1c/Insulin Use Response at Week 12 and Months 6 and 12 [ Time Frame: Week 12 and Months 6 and 12 ]
    A participant was considered a responder if, at the given time point, the participant had HbA1c<= 6.5%, and mean daily insulin use over 7 consecutive days < 0.5 international units per kilogram per day (IU/kg/day) during the 2 weeks preceding the visit. Data has been presented from number of participants with their percentages who were responders at Week 12 and Months 6 and 12.

  • Mean Daily Insulin Use at Week 12 and Months 6 and 12. [ Time Frame: Week 12 and Months 6 and 12. ]
    Participants recorded their daily insulin use in their electronic diaries. In particular, insulin was recorded thoroughly and accurately for at least 7 consecutive days during the 2 weeks before the visits at Baseline, Week 12, and Months 6 and 12. During each of these visits, the investigator/designee accessed the invivodata DiaryPRO web site to review insulin-use data for the previous 2-week period to ensure completeness. If errors/gaps were identified (e.g., if the participant did not take insulin and not entered 0 units), the investigator/designee recorded the missing data from participant recall using a data clarification form (DCF). Paper diary to collect insulin use, were reviewed for completeness. Any missing data that could be recalled by the participant was entered. If the participant did not record any insulin use during the 2-week period before the visit, the site obtained an insulin use history for the previous 7 days and calculated the average daily insulin dose.

  • HbA1c Level at Week 12 and Months 6 and 12 [ Time Frame: Week 12 and Months 6 and 12 ]
    HbA1c levels were recorded at Screening, Baseline (Day 1), Day 28, Week 8, Week 12, Months 4 to 12 and Month 24. Data has been presented for HbA1c levels at Week 12 and Months 6 and 12.

  • Number of Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12 [ Time Frame: Upto Month 12 ]
    Hypoglycemic events reported by participants were classified as defined by the American Diabetes Association (ADA) Workgroup on Hypoglycemia as follows: Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration(PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL.

  • Number of Participants With Hypoglycemic Events Defined by Hypoglycemic Event Categories From Baseline Upto Month 12 [ Time Frame: Upto Month 12 ]
    Hypoglycemic events reported by participants were classified as defined by the ADA Workgroup on Hypoglycemia as Severe hypoglycemia: an event requiring assistance of another person to actively administer carbohydrate, glucagon/other resuscitative actions, documented symptomatic hypoglycemia: an event during which typical symptoms of hypoglycemia are accompanied by a measured plasma glucose concentration (PGC)<=70 mg/dL, asymptomatic hypoglycemia: an event not accompanied by typical symptoms of hypoglycemia but with a measured PGC<=70 mg/dL,probable symptomatic hypoglycemia: an event during which symptoms of hypoglycemia are not accompanied by a plasma glucose determination, but were presumably caused by a PGC<=70 mg/dL and relative hypoglycemia: an event during which the person with diabetes reports any of the typical symptoms of hypoglycemia, and interprets the symptoms as indicative of hypoglycemia, but with a measured PGC>70 mg/dL. Only categories with values are presented.

  • Number of Hypoglycemic Excursions (<=70 mg/dL) With Most Complete Glucose at Week 12 and Months 6 and 12. [ Time Frame: Week 12 and Months 6 and 12. ]
    The event frequency of glucose measurements that were hypoglycemic excursions were calculated per participant basis, using the number of occurrences where blood glucose was less than or equal to 70 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.

  • Magnitude of Greatest Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12. [ Time Frame: Week 12 and Months 6 and 12. ]

    The greatest hypoglycemic excursions during an interval was calculated as 70 mg/dL minus the lowest recorded glucose level in the interval. If a participant had data recorded during the interval but did not have a value below 70 mg/dL, the participants greatest hypoglycemic excursion for that interval was 0 mg/dL.

    Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.


  • Number of Participants With Hypoglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12 [ Time Frame: Week 12 and Months 6 and 12 ]
    Percentage of hypoglycemic excursions was calculated as the total number of observations that exceed the hypoglycemic excursion boundary (i.e.<= 70 mg/dL) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data has been presented for number of participants with their percentages having hypoglycemic excursion.

  • Number of Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12. [ Time Frame: Week 12 and Months 6 and 12 ]
    The event frequency of glucose measurements that were hyperglycemic excursions were calculated on a per participant basis using the number of occurrences where blood glucose was greater than the hyperglycemic tolerance limit. There were 3 hyperglycemic tolerance limits considered: 200 mg/dL, 130 mg/dL and 100 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.

  • Magnitude of Greatest Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12. [ Time Frame: Week 12 and Months 6 and 12. ]
    The greatest hyperglycemic excursions during an interval was calculated as the largest recorded glucose level in the interval minus the hyperglycemic tolerance limit value (HGTLV). If a participant had data recorded during the interval but did not have a value above the HGTLV, the participants greatest hyperglycemic excursion for that interval was 0 mg/dL. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected.

  • Number of Participants With Hyperglycemic Excursions With Most Complete Glucose at Week 12 and Months 6 and 12 [ Time Frame: Week 12 and Months 6 and 12 ]
    Percentage of hyperglycemic excursions was calculated as the total number of observations that exceed the hyperglycemic excursion boundary (i.e. > HGTLV) divided by the total number of glucose measurements recorded in a time interval for the intervals: Baseline to Week 12, post-Week 12 to Month 6, post-Month 6 to Month 12. Most complete glucose interval was the 7 day period with the maximum number of days with at least 4 recordings per day. If these results were in more than one 7 day period, then the 7 day period with the largest average number of daily recordings (out of those with the maximum number of days with at least 4 recordings per day) was selected. If there were 2 or more 7 day periods that have the same number of days with at least 4 recordings and the same maximum average number of glucose recordings, the period that ended closest to the day of the study was selected. Data for number of participants with their percentages are presented.

  • Change From Baseline in Average Daily Risk Range (ADRR) at Week 12 and Months 6 and 12. [ Time Frame: Baseline (Day 1) and Week 12, Months 6 and 12. ]
    Average daily risk range is a measure for evaluation of blood glucose variability that was designed to be equally sensitive to hypoglycemia and hyperglycemia. The ADRR was assessed over 30-day periods prior to Baseline and at key visits Week 12 and Months 6 and 12. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Week 12 and Months 6 and 12.

  • Composite Rank Summary for HbA1c and Exogenous Insulin Use at Month 6 and Month 12 [ Time Frame: Month 6 and 12 ]
    O'Brien mean rank analyses was performed on a two-part composite of the baseline-adjusted HbA1c level and the baseline-adjusted mean total daily insulin use per kg body weight in the otelixizumab group compared with the placebo group at Months 6, 12. For the O'Brien mean rank analysis at a particular time point, adjusted HbA1c values (for both treatment groups together) was ranked from smallest to largest, and adjusted mean daily insulin use values were ranked from smallest to largest. For each participant, the HbA1c and insulin use ranks were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.

  • Composite Rank Summary for C-Peptide AUC, HbA1c and Exogenous Insulin Use at Month 6 and Month 12 [ Time Frame: Month 6 and 12 ]
    O'Brien analyses will be performed on a three-part composite of HbA1c level, C-peptide AUC, and mean daily Insulin use in the otelixizumab group compared with the placebo group at Months 6 and12. For the O'Brien mean rank analysis at a particular time point, HbA1c and insulin use will be ranked from smallest to largest, and C-peptide AUC will be ranked from largest to smallest. For each participant, the C-Peptide AUC, ranks for HbA1c and insulin use were added together, producing a composite rank. A treatment comparison test was then performed on the composite ranks.

  • Change From Baseline in Level of Cytokines Interleukin (IL-6), IL-10 and Tumor Necrosis Factor-alpha (TNF-a) at Day 1, Day 4, Day 8 [ Time Frame: Day 1, Day 4, Day 8 ]
    Levels of cytokine (TNFα, IL-6, IL-10) were measured at Baseline and at 2 hours after end of infusion (EOI) on Day 1, Day 4, Day 8 . Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.

  • Percent Change From Baseline in Circulating Peripheral Lymphocytes CD4+CD25+FoxP3+ T Cells and CD4+CD25hiFoxP3+ T Cells in Type 1 Diabetes Mellitus (TIDM) up to Month 12 [ Time Frame: Baseline (pre-dose on Day 1) and up to 12 Months ]
    Blood samples were drawn for lymphocyte subset evaluations at Baseline and at 2hours after EOI on Day 4, pre-dose and after E0I on Day 8, Day 14, Day 21, Day 28, Week 6, Week 8, Week 10, Week 12, Month 6 and Month 12. Percentages of relevant lymphocyte subsets were determined by flow cytometry. The lymphocyte subsets assessed included CD8+CD25+ T lymphocytes, as well as the subsets of lymphocytes of these type that were positive for FoxP3, a protein that was expressed at high levels in the cytoplasm of regulatory T cells. CD4+CD25hiFoxP3+ T lymphocytes, a cell type was of interest because it played a regulatory role in T1DM. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at the time of assessment.

  • Percent Change From Baseline in Cell-bound Otelixizumab on CD4+ T Cells at Day 1, Day 4, Day 8 [ Time Frame: Baseline (pre-dose on Day 1), Day 4 and Day 8 ]
    The amount of cell-bound otelixizumab was determined by flow cytometry. The extent of T cell receptor alpha beta (TCRαβ) expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. Free otelixizumab binding sites (sites not occupied by otelixizumab) were detected by staining with biotinylated otelixizumab. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of bound antibody on CD4+ T cells was a direct measurement of cell-bound otelixizumab on CD4+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.

  • Percent Change From Baseline in CD3/TCR Saturation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8 [ Time Frame: Baseline (Pre-dose Day 1), Day 4, Day 8 ]
    The extent of saturation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites. MESF of free CD3 sites on CD4+ T cells and CD8+ T cells was direct measurement of saturation of the CD3/TCR complex on CD4+ T cells and CD8+ T cells. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.

  • Percent Change From Baseline in CD3/TCR Modulation on CD4+ T Cells and CD8+ T Cells at Day 1, Day 4, Day 8 [ Time Frame: Baseline (Pre-dose Day 1), Day 4, Day 8 ]
    The extent of modulation of CD3/TCR receptors on CD4+ and CD8+ lymphocytes was determined by flow cytometry. The extent of TCRαβ expression was determined using an antibody that bound to TCRαβ but did not compete with otelixizumab for binding sites at the expected range of concentrations. The MESF of the anti-TCRαβ antibody was used to quantify the number of CD3/TCR complexes present on T cells. The MESF of bound biotinylated otelixizumab was directly proportional to the availability of free otelixizumab binding sites.CD3/TCR complexes on CD4+ and CD8+ T cells were detected with a non-competing antibody. Changes in the MESF of TCR expression was a direct measurement of TCR modulation. Baseline assessments were carried out on the morning of Day 1, before the start of the first infusion of study drug. Change from Baseline was calculated by subtracting the Baseline value from the post-randomization value at Day 1, Day 4 and Day 8.


Enrollment: 272
Actual Study Start Date: July 29, 2008
Study Completion Date: January 31, 2012
Primary Completion Date: January 31, 2012 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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, D.C., 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, 33136
GSK Investigational Site
Miami, Florida, United States, 33169
GSK Investigational Site
Orlando, Florida, United States, 32803
GSK Investigational Site
Orlando, Florida, United States, 32835
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
Saint Louis, Missouri, United States, 63110
United States, Nebraska
GSK Investigational Site
Omaha, Nebraska, United States, 68131
United States, New Jersey
GSK Investigational Site
Neptune City, 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, 75231
GSK Investigational Site
Dallas, Texas, United States, 75390
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
Smiths 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, 00157
GSK Investigational Site
Roma, Lazio, Italy, 00161
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:
Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 115495
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00678886     History of Changes
Obsolete Identifiers: NCT00893022
Other Study ID Numbers: 115495
TRX4006 ( Other Identifier: Tolerx )
First Submitted: May 13, 2008
First Posted: May 16, 2008
Results First Submitted: July 19, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017
Last Verified: July 2017

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