Clinical trial NCT00627146: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, type 1
ChAgly CD3
Lead sponsor: AZ-VUB
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Universiteit Antwerpen
name: Erasme University Hospital
First posted: 2008-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The difference in change in daily insulin need between baseline and month 48, between placebo and ChAgly CD3 treated patients
timeFrame: 48 months
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Brussels
country: Belgium
facility: Universitair Ziekenhuis and Diabetes Research Center - Brussels Free University-VUB
city: Brussel
country: Belgium
facility: Hopital Erasme
city: Leuven
country: Belgium
facility: Department of Endocrinology and Nephrology, UZ Gasthuisberg, Katholieke Universiteit Leuven -KUL
city: Munich
country: Germany
facility: Hopital Schwabbing
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Bart Keymeulen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.