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

Primary Purpose

Diabetes Mellitus, Type 1

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

ChAgly CD3

Placebo

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, type 1, ChAgly CD3

Eligibility Criteria

12 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Universitair Ziekenhuis Antwerpen
Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
Hopital Erasme
Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
Hopital Schwabbing

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

ChAgly CD3

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00627146

First Posted

February 22, 2008

Last Updated

September 25, 2008

Sponsor

AZ-VUB

Collaborators

KU Leuven, Universiteit Antwerpen, Erasme University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00627146

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Completed

Study Start Date

June 2000 (undefined)

Primary Completion Date

March 2007 (Actual)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AZ-VUB

Collaborators

KU Leuven, Universiteit Antwerpen, Erasme University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, type 1, ChAgly CD3

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Active Comparator

Arm Description

ChAgly CD3

Intervention Type

Drug

Intervention Name(s)

ChAgly CD3

Intervention Description

6 days treatment 8mg/d intravenous

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

6 days

Primary Outcome Measure Information:

Title

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

Time Frame

48 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bart Keymeulen, MD,PhD

Organizational Affiliation

Universitair Ziekenhuis Brussel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitair Ziekenhuis Antwerpen

City

Antwerpen

Country

Belgium

Facility Name

Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB

City

Brussels

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Hopital Erasme

City

Brussel

Country

Belgium

Facility Name

Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Hopital Schwabbing

City

Munich

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

15972866

Citation

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. doi: 10.1056/NEJMoa043980.

Results Reference

background

PubMed Identifier

20225393

Citation

Keymeulen B, Walter M, Mathieu C, Kaufman L, Gorus F, Hilbrands R, Vandemeulebroucke E, Van de Velde U, Crenier L, De Block C, Candon S, Waldmann H, Ziegler AG, Chatenoud L, Pipeleers D. Four-year metabolic outcome of a randomised controlled CD3-antibody trial in recent-onset type 1 diabetic patients depends on their age and baseline residual beta cell mass. Diabetologia. 2010 Apr;53(4):614-23. doi: 10.1007/s00125-009-1644-9. Epub 2010 Jan 14.

Results Reference

derived

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

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