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TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

TRX4 Therapeutic Evaluation of Different Multi-Dose Regimens in Type 1 Diabetes Mellitus (TTEDD)

NCT00451321•GlaxoSmithKline

Summary

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.

Eligibility

Age

12 - 45 years

Sex

ALL

Healthy Volunteers

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

Locations (17)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Walnut Creek, California, United States

GSK Investigational Site

Aurora, Colorado, United States

GSK Investigational Site

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

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Pinellas Park, Florida, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Worcester, Massachusetts, United States

GSK Investigational Site

Kalamazoo, Michigan, United States

Key Dates

Start Date

July 31, 2006

Primary Completion Date

December 1, 2011

Completion Date

December 1, 2011

Last Updated

November 13, 2017

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus, Type 1

Interventions

Otelixizumab

DRUG

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

NCT04786262

Diabetes Mellitus, Type 1Impaired Hypoglycemic Awareness+1 more

View study

RECRUITINGNA

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

NCT06748963

Diabetes Mellitus, Type 1

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 13, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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TRX4 Monoclonal Antibody in Type 1 Diabetes (T1 DM)

Inclusion Criteria

Exclusion Criteria

A Safety, Tolerability, and Efficacy Study of VX-880 in Participants With Type 1 Diabetes

Fasted Exercise Training in Type 1 Diabetes (FED-T1D)

Closed Loop and Education for Hypoglycemia Awareness Restoration

A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes

Achieving Health in Emerging Adults With Diabetes (AHEAD) Program: A Clinical Trial Designed to Understand if Participation in a Clinical Program Developed Specifically to Support Emerging Adults With Type 1 Diabetes Leads to Improved Diabetes Outcomes.

Repeat BCG Vaccinations For The Treatment Of Pediatric Type 1 Diabetes