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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

May 11, 2010
December 13, 2012
May 2010
March 2012   (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 ]
Same as current
Complete list of historical versions of study NCT01123083 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 Week 12, Months 6, 12, 18, and 24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Trial of Otelixizumab for Adolescents and Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-2
DEFEND 2: Durable-Response Therapy Evaluation ForEarly- or New-Onset Type 1 Diabetes

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.

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.
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
    Other Names:
    • ChAglyCD3
    • TRX4
    • monoclonal antibody
    • anti-CD3
  • Biological: Placebo
    Infusion
  • Experimental: otelixizumab
    otelixizumab
    Intervention: Biological: Otelixizumab
  • Placebo Comparator: placebo
    placebo
    Intervention: Biological: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
179
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Canada,   Denmark,   Finland,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   United Kingdom
 
NCT01123083
115494, TRX4018
Yes
GlaxoSmithKline
GlaxoSmithKline
Juvenile Diabetes Research Foundation
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
December 2012

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