Extension of Phase II Therapeutic Trial With a Humanized Non-Mitogenic CD3 (ChAgly CD3) Monoclonal Antibody in Recently Diagnosed Type 1 Diabetic Patients

Phase 2

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Drug: Placebo; Drug: ChAgly CD3

• Registration Number: NCT00627146
• Lead Sponsor: AZ-VUB

Brief Summary

Compared to placebo, treatment with ChAgly CD3 has a beneficial effect on preservation of beta cell function and metabolic outcome in type 1 diabetic patients with recent clinical onset of disease that persists until 48 months after administration.

The investigators also hypothesize that in type 1 diabetic patients with recent clinical onset of disease compared to placebo, ChAgly CD3 will be safe and well tolerated between 18 and 48 months after administration, based on assessment of clinical and laboratory adverse events.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-06
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Study First Submitted: 2008-02-22
• Study First Submitted QC: 2008-02-22
• Study First Posted: 2008-02-29
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-25
• Last Update Posted: 2008-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Subjects with Type 1 diabetes mellitus included in the phase II therapeutic trial with a humanized non-mitogenic CD3 monoclonal antibody (ChAgly CD3) at time of clinical diagnosis and who agree and are likely to comply with the investigator's instructions

Exclusion Criteria

• Any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risks to the patient
• Use of illicit drugs or over consumption of alcohol (> 3 beers/day)
• Being legally incapacitated, having significant emotional problems at the time of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Placebo	-
A	ChAgly CD3	ChAgly CD3

Primary Outcome Measures

Name	Time	Method
The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients	48 months

Trial Locations

Locations (5)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB; 🇧🇪 Brussels, Belgium

Hopital Erasme; 🇧🇪 Brussel, Belgium

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL; 🇧🇪 Leuven, Belgium

Hopital Schwabbing; 🇩🇪 Munich, Germany