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

  Show 109 Study Locations
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, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014