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

GlaxoSmithKline (GSK)

Status and phase: Terminated; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Otelixizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00451321

TRX4005 (Other Identifier)

115493

Details and patient eligibility

About

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.

Enrollment: 88 patients

Sex: All

Ages: 12 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

88 participants in 1 patient group

otelixizumab

Experimental group

Treatment:

Drug: Otelixizumab