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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627146
• Other study ID #: BK-AntiCD3-02
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2008
• Last updated: September 25, 2008
• Start date: June 2000
• Est. completion date: March 2007

Study information

• Verified date: September 2008
• Source: AZ-VUB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• ChAgly CD3
6 days treatment 8mg/d intravenous
• Placebo
6 days

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Hopital Erasme	Brussel
Belgium	Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB	Brussels
Belgium	Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL	Leuven
Germany	Hopital Schwabbing	Munich

Sponsors (4)

Lead Sponsor	Collaborator
AZ-VUB	Erasme University Hospital, Katholieke Universiteit Leuven, Universiteit Antwerpen

Countries where clinical trial is conducted

Belgium,  Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients		48 months	No