NCT01222078

Investigating Re-Dosing With Otelixizumab in Adults With Newly-Diagnosed Type 1 Diabetes Mellitus

Terminated Phase 2 Results posted Last updated 30 October 2020

What this trial tests

Phase 2 trial testing otelixizumab in Diabetes Mellitus, Type 1 in 1 participant. Terminated before completion.

Timeline

22 November 2010

Primary endpoint
19 May 2011

19 May 2011

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	22 November 2010
Primary completion	19 May 2011
Estimated completion	19 May 2011
Sites	2 locations across France, Germany

Drugs / interventions tested

• otelixizumab — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 45, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Any Adverse Events (AEs) and Serious AEs (SAEs) Primary · Up to Month 24

AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE include adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threate

Any AEs

Group	Value	95% CI
Otelixizumab	1

Any SAEs

Group	Value	95% CI
Otelixizumab	0

Number of Participants With Values Outside the Normal Range for Vitals Primary · Up to Month 24

Vital included assessment of SBP, DBP, respiration rate, heart rate and temperature were assessed at sitting position. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early study termination.

SBP and DBP

Group	Value	95% CI
Otelixizumab	1

Respiration rate

Group	Value	95% CI
Otelixizumab	1

Heart rate

Group	Value	95% CI
Otelixizumab	1

Temperature

Group	Value	95% CI
Otelixizumab	0

Mean Epstein-Barr Virus (EBV) Viral Load Primary · Up to Month 24

Levels of EBV were assessed periodically using Quantitative Polymerase Chain Reaction. If a participant had an EBV viral load of \>=10,000 copies per 10\^6 Peripheral Blood Mononuclear Cells (PBMCs) at any visit, the test was repeated as soon as possible to confirm this result. If the result was confirmed, the test was repeated weekly for 2 weeks or until the count decreases to \< 10,000 copies per 10\^6 PBMCs, whichever was longer. The EBV Load remained zero throughout the study. Participant did not received re-dose of second treatment period and withdrew on study Day 164 because of early stu

Group	Value	95% CI
Otelixizumab	0	± NA

Mean Change in CD4+ and CD8+ T-cell Counts Primary · Days 1, 4 and 8 of each treatment course

CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Mean Change in Circulating Peripheral T Lymphocytes Primary · Days 1, 4 and 8 of each treatment course

Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Mean Change in Circulating Peripheral CD4+ and CD8+ Subset Counts Primary · Days 1, 4 and 8 of each treatment course

Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Mean Circulating Peripheral T Lymphocytes Count Secondary · Day 1, 4 and 8 of each treatment course

Circulating peripheral T lymphocytes were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Mean Circulating CD4+ and CD8+ Subset Counts Secondary · Days 1, 4 and 8 of each treatment course

Circulating peripheral CD4+ and CD8+ T cells were planned to be measured before, during and after dose 1, 4 and 8 of first treatment course. Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Overall Study Arm	NA	± NA

Mean Saturation of CD3 Antigen on Peripheral Blood T Cells Secondary · Days 1, 4 and 8 of each treatment course

Assessment of CD3 antigen was planned to be done on Day 1, 4 and 8 of first treatment course. The data was planned to be presented with unit Molecules of Equivalent Soluble Fluorochrome (MESF). Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Mean Individual Serum Concentrations of Otelixizumab Secondary · Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course

Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Maximum Observed Serum Concentration (Cmax) of Otelixizumab Secondary · Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course

Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	± NA

Time to Cmax (Tmax) of Otelixizumab Secondary · Pre-dose and EOI on Dosing Day 1, EOI on Dosing Days 2, 3, 5-7 and Pre-dose, EOI, 6 hours post SOI on Dosing days 4 and 8 of each treatment course

Because of the early termination of the study the data was not analyzed.

Group	Value	95% CI
Otelixizumab	NA	NA – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: All AEs and SAEs were reported since first dose of investigational product up to Month 24.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Otelixizumab

Serious: 0/1 (0%)

Deaths: —

Other adverse events (4 terms — click to expand)

Reaction	System	Otelixizumab
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT01222078 adverse events section.

Sponsor's own description

The purpose of this study to assess the safety and tolerability of re-dosing at 6 months with otelixizumab (given as an 8-day series of intravenous infusions) in adult subjects with newly diagnosed type 1 diabetes mellitus

Publications & conference data

No peer-reviewed publications indexed yet for this trial.