MedDataX Logo

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

NCT ID: NCT00678886

Last Updated: 2017-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-29

Study Completion Date

2012-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 1

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

otelixizumab

otelixizumab

Group Type EXPERIMENTAL

otelixizumab infusion plus physician determined standard of care

Intervention Type BIOLOGICAL

infusion

placebo

Placebo

Group Type PLACEBO_COMPARATOR

placebo infusion plus physician determined standard of care

Intervention Type BIOLOGICAL

infusion

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

otelixizumab infusion plus physician determined standard of care

infusion

Intervention Type BIOLOGICAL

placebo infusion plus physician determined standard of care

infusion

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

monoclonal antibody ChAglyCD3 anti-CD3 TRX4

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

GSK Investigational Site

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Little Rock, Arkansas, United States

Site Status

GSK Investigational Site

Costa Mesa, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Orange, California, United States

Site Status

GSK Investigational Site

Riverside, California, United States

Site Status

GSK Investigational Site

Santa Ana, California, United States

Site Status

GSK Investigational Site

Torrance, California, United States

Site Status

GSK Investigational Site

Walnut Creek, California, United States

Site Status

GSK Investigational Site

Aurora, Colorado, United States

Site Status

GSK Investigational Site

Washington D.C., District of Columbia, United States

Site Status

GSK Investigational Site

Boca Raton, Florida, United States

Site Status

GSK Investigational Site

Jupiter, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Miami, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Orlando, Florida, United States

Site Status

GSK Investigational Site

Pembroke Pines, Florida, United States

Site Status

GSK Investigational Site

Trinity, Florida, United States

Site Status

GSK Investigational Site

Winter Park, Florida, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Atlanta, Georgia, United States

Site Status

GSK Investigational Site

Honolulu, Hawaii, United States

Site Status

GSK Investigational Site

Boise, Idaho, United States

Site Status

GSK Investigational Site

Idaho Falls, Idaho, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Chicago, Illinois, United States

Site Status

GSK Investigational Site

Indianapolis, Indiana, United States

Site Status

GSK Investigational Site

Atlanta, Kansas, United States

Site Status

GSK Investigational Site

Topeka, Kansas, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

Worcester, Massachusetts, United States

Site Status

GSK Investigational Site

Detroit, Michigan, United States

Site Status

GSK Investigational Site

Kalamazoo, Michigan, United States

Site Status

GSK Investigational Site

Gulfport, Mississippi, United States

Site Status

GSK Investigational Site

Columbia, Missouri, United States

Site Status

GSK Investigational Site

Kansas City, Missouri, United States

Site Status

GSK Investigational Site

St Louis, Missouri, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Neptune City, New Jersey, United States

Site Status

GSK Investigational Site

Buffalo, New York, United States

Site Status

GSK Investigational Site

Mineola, New York, United States

Site Status

GSK Investigational Site

New York, New York, United States

Site Status

GSK Investigational Site

Rochester, New York, United States

Site Status

GSK Investigational Site

Durham, North Carolina, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Columbus, Ohio, United States

Site Status

GSK Investigational Site

Dayton, Ohio, United States

Site Status

GSK Investigational Site

Mentor, Ohio, United States

Site Status

GSK Investigational Site

Tulsa, Oklahoma, United States

Site Status

GSK Investigational Site

Eugene, Oregon, United States

Site Status

GSK Investigational Site

Portland, Oregon, United States

Site Status

GSK Investigational Site

Langhorne, Pennsylvania, United States

Site Status

GSK Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

GSK Investigational Site

Charleston, South Carolina, United States

Site Status

GSK Investigational Site

Rapid City, South Dakota, United States

Site Status

GSK Investigational Site

Chattanooga, Tennessee, United States

Site Status

GSK Investigational Site

Memphis, Tennessee, United States

Site Status

GSK Investigational Site

Nashville, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Hurst, Texas, United States

Site Status

GSK Investigational Site

San Antonio, Texas, United States

Site Status

GSK Investigational Site

Schertz, Texas, United States

Site Status

GSK Investigational Site

Ogden, Utah, United States

Site Status

GSK Investigational Site

Tacoma, Washington, United States

Site Status

GSK Investigational Site

Calgary, Alberta, Canada

Site Status

GSK Investigational Site

Oakville, Ontario, Canada

Site Status

GSK Investigational Site

Smiths Falls, Ontario, Canada

Site Status

GSK Investigational Site

Toronto, Ontario, Canada

Site Status

GSK Investigational Site

Montreal, Quebec, Canada

Site Status

GSK Investigational Site

Pointe-Claire, Quebec, Canada

Site Status

GSK Investigational Site

Arhus C, , Denmark

Site Status

GSK Investigational Site

Tampere, , Finland

Site Status

GSK Investigational Site

Turku, , Finland

Site Status

GSK Investigational Site

Heidelberg, Baden-Wurttemberg, Germany

Site Status

GSK Investigational Site

Bad Nauheim, Hesse, Germany

Site Status

GSK Investigational Site

Bad Lauterberg im Harz, Lower Saxony, Germany

Site Status

GSK Investigational Site

Berlin, , Germany

Site Status

GSK Investigational Site

Latina, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Rome, Lazio, Italy

Site Status

GSK Investigational Site

Monserrato, Sardinia, Italy

Site Status

GSK Investigational Site

Palermo, Sicily, Italy

Site Status

GSK Investigational Site

Milan, , Italy

Site Status

GSK Investigational Site

Roma, , Italy

Site Status

GSK Investigational Site

Barcelona, , Spain

Site Status

GSK Investigational Site

Girona, , Spain

Site Status

GSK Investigational Site

Madrid, , Spain

Site Status

GSK Investigational Site

Sant Joan, , Spain

Site Status

GSK Investigational Site

Tarrasa, Barcelona, , Spain

Site Status

GSK Investigational Site

Gothenburg, , Sweden

Site Status

GSK Investigational Site

Halmstad, , Sweden

Site Status

GSK Investigational Site

Härnösand, , Sweden

Site Status

GSK Investigational Site

Karlskrona, , Sweden

Site Status

GSK Investigational Site

Karlstad, , Sweden

Site Status

GSK Investigational Site

Kristianstad, , Sweden

Site Status

GSK Investigational Site

Motala, , Sweden

Site Status

GSK Investigational Site

Stockholm, , Sweden

Site Status

GSK Investigational Site

Umeå, , Sweden

Site Status

GSK Investigational Site

Vaxjo, , Sweden

Site Status

GSK Investigational Site

Bath, Somerset, United Kingdom

Site Status

GSK Investigational Site

Blackburn, , United Kingdom

Site Status

GSK Investigational Site

Bristol, , United Kingdom

Site Status

GSK Investigational Site

Hull, , United Kingdom

Site Status

GSK Investigational Site

London, , United Kingdom

Site Status

GSK Investigational Site

Newcastle upon Tyne, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada Denmark Finland Germany Italy Spain Sweden United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Keymeulen B, Vandemeulebroucke E, Ziegler AG, Mathieu C, Kaufman L, Hale G, Gorus F, Goldman M, Walter M, Candon S, Schandene L, Crenier L, De Block C, Seigneurin JM, De Pauw P, Pierard D, Weets I, Rebello P, Bird P, Berrie E, Frewin M, Waldmann H, Bach JF, Pipeleers D, Chatenoud L. Insulin needs after CD3-antibody therapy in new-onset type 1 diabetes. N Engl J Med. 2005 Jun 23;352(25):2598-608. doi: 10.1056/NEJMoa043980.

Reference Type BACKGROUND
PMID: 15972866 (View on PubMed)

You S, Candon S, Kuhn C, Bach JF, Chatenoud L. CD3 antibodies as unique tools to restore self-tolerance in established autoimmunity their mode of action and clinical application in type 1 diabetes. Adv Immunol. 2008;100:13-37. doi: 10.1016/S0065-2776(08)00802-X. No abstract available.

Reference Type BACKGROUND
PMID: 19111162 (View on PubMed)

Study Documents

Access uploaded study-related documents such as protocols, statistical analysis plans, or lay summaries.

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

Access external resources that provide additional context or updates about the study.

http://www.defendagainstdiabetes.com/

Website containing information on DEFEND study

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRX4006

Identifier Type: OTHER

Identifier Source: secondary_id

115495

Identifier Type: -

Identifier Source: org_study_id

NCT00893022

Identifier Type: -

Identifier Source: nct_alias