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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1

Treatments: Biological: placebo infusion plus physician determined standard of care; Biological: otelixizumab infusion plus physician determined standard of care

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00678886

TRX4006 (Other Identifier)

115495

Details and patient eligibility

About

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

Full 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.

Enrollment: 272 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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272 participants in 2 patient groups, including a placebo group

otelixizumab

Experimental group

Description:

otelixizumab

Treatment:

Biological: otelixizumab infusion plus physician determined standard of care

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Biological: placebo infusion plus physician determined standard of care