TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) - Full Text View

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) (TTEDD)

This study is ongoing, but not recruiting participants.

First Received on March 21, 2007. Last Updated on October 6, 2011 History of Changes

Sponsor:	GlaxoSmithKline
Collaborator:	Juvenile Diabetes Research Foundation
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00451321

Purpose

The purpose of this study is to optimize several multi-dose regimens of otelixizumab, determine the highest biologically active dose, evaluate biomarkers and surrogates of efficacy, and to evaluate the effects of each multi-dose regimen of otelixizumab against standard safety and efficacy parameters.

Condition	Intervention	Phase
Type 1 Diabetes Mellitus	Drug: Otelixizumab	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Type 1

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Define highest tolerated dose regimen that has negligible cytokine release, and no clinically significant reactivation of EBV. Evaluate effects of different dose regimens on safety parameters and EBV reactivation. [ Time Frame: up to 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	100
Study Start Date:	July 2006
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: otelixizumab	Drug: Otelixizumab Infusion

Eligibility

Ages Eligible for Study:	12 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Adults 12 to 45 years old who are in good general health
Confirmed diagnosis of insulin requiring type 1 diabetes mellitus with good glycemic control
Measurable C-peptide levels

Exclusion Criteria:

Females must not be pregnant or lactating and willing to practice contraception
No prior malignancy, other than non-melanoma skin cancer
Body Mass Index (BMI) > 32 at screening

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00451321

Sponsors and Collaborators

GlaxoSmithKline

Juvenile Diabetes Research Foundation

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

Publications:

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.

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00451321 History of Changes
Other Study ID Numbers:	115493, TRX4005
Study First Received:	March 21, 2007
Last Updated:	October 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

type 1 diabetes mellitus
diabetes mellitus type 1
type 1 diabetes
diabetes mellitus
diabetes

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases

Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012