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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01123083
First Posted: May 14, 2010
Last Update Posted: September 15, 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
Results First Submitted: August 17, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Type 1
Interventions: Biological: Otelixizumab
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted across 73 centers in 10 countries (Belgium, Canada, Germany, Denmark, Spain, Finland, United Kingdom, Italy, Sweden, and United States of America) from 17 May 2010 to 09 March 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 179 participants (125 adults and 54 adolescents) were randomized in this study and included in safety and intent-to-treat (ITT) population.

Reporting Groups
  Description
Placebo Eligible participants received Placebo matching otelixizumab 3.1 milligrams (mg) as intravenous (IV) infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
Otelixizumab Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.

Participant Flow:   Overall Study
    Placebo   Otelixizumab
STARTED   61   118 
COMPLETED   50   103 
NOT COMPLETED   11   15 
Investigator recommendation                1                1 
Administrative reasons                0                4 
Lost to Follow-up                2                6 
Adverse Event                1                0 
Withdrew for another reason not covered                0                1 
Participant/legal representative request                7                3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Eligible participants received Placebo matching otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
Otelixizumab Eligible participants received otelixizumab 3.1 mg as IV infusion, with each infusion given over a 30-minute period. Participants received a series of 8 infusions, 1 infusion per day over 8 consecutive days.
Total Total of all reporting groups

Baseline Measures
   Placebo   Otelixizumab   Total 
Overall Participants Analyzed 
[Units: Participants]
 61   118   179 
Age 
[Units: Years]
Mean (Standard Deviation)
 22.5  (8.22)   23.6  (8.34)   23.2  (8.29) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      24  39.3%      50  42.4%      74  41.3% 
Male      37  60.7%      68  57.6%      105  58.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      1   1.6%      1   0.8%      2   1.1% 
Asian      1   1.6%      2   1.7%      3   1.7% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   1.6%      2   1.7%      3   1.7% 
White      54  88.5%      111  94.1%      165  92.2% 
More than one race      4   6.6%      2   1.7%      6   3.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 (Day 1) and Month 12 ]

2.  Secondary:   Change From Baseline in 2 Hour Mixed Meal-stimulated C-peptide AUC (Normalized for 120-minute Time Interval) at Week 12 and 6 Months   [ Time Frame: Baseline (Day 1) and Week 12, Month 6 ]

3.  Secondary:   Change From Baseline in Stimulated C-Peptide Mean AUC at Week 12, Month 6, 12 and 18   [ Time Frame: Baseline (Day 1) and Week 12, Month 6, 12, 18 ]

4.  Secondary:   Number of Participants With Responder Status   [ Time Frame: Month 3, 6 and 12 ]

5.  Secondary:   Change From Baseline in Mean Daily Insulin Use Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment   [ Time Frame: Baseline (Day 1) and Month 3, 6, 12 ]

6.  Secondary:   Change From Baseline in HbA1c Levels Over 7 Consecutive Days During the 2 Weeks Prior to the Assessment   [ Time Frame: Baseline (Day 1) and Month 3, 6, 12 ]

7.  Secondary:   Average Number of Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events From Baseline to Month 12   [ Time Frame: Baseline (Day 1) and Month 12 ]

8.  Secondary:   Percentage of Participants With Change From Baseline in Severe Hypoglycemic Events and Documented Symptomatic Hypoglycemic Events at Month 12   [ Time Frame: Baseline (Day 1) and Month 12 ]

9.  Secondary:   Composite Rank Sum: HbA1c and Exogenous Insulin Use at 6 and 12 Months   [ Time Frame: Month 6 and 12 ]

10.  Secondary:   Composite Rank Sum: C-Peptide AUC, HbA1c and Exogenous Insulin Use at 6 and 12 Months   [ Time Frame: Month 6 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01123083     History of Changes
Other Study ID Numbers: 115494
TRX4018 ( Other Identifier: Tolerx )
First Submitted: May 11, 2010
First Posted: May 14, 2010
Results First Submitted: August 17, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017