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

May 13, 2008
February 7, 2013
July 2008
December 2010   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00678886 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1
Durable-Response Therapy Evaluation ForEarly or New-Onset Type 1 Diabetes - DEFEND

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
  • Biological: otelixizumab infusion plus physician determined standard of care
    infusion
    Other Names:
    • monoclonal antibody
    • ChAglyCD3
    • anti-CD3
    • TRX4
  • Biological: placebo infusion plus physician determined standard of care
    infusion
  • Experimental: otelixizumab
    otelixizumab
    Intervention: Biological: otelixizumab infusion plus physician determined standard of care
  • Placebo Comparator: placebo
    Placebo
    Intervention: Biological: placebo infusion plus physician determined standard of care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
January 2012
December 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 45 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Denmark,   Finland,   Germany,   Italy,   Spain,   Sweden,   United Kingdom
 
NCT00678886
115495, TRX4006
Yes
GlaxoSmithKline
GlaxoSmithKline
Juvenile Diabetes Research Foundation
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP