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Test the Effects of Otelixizumab for Individuals With Recently Diagnosed Diabetes
This study is currently recruiting participants.
Verified by Clinical Innovations, May 2009
First Received: May 1, 2009   No Changes Posted
Sponsored by: Clinical Innovations
Information provided by: Clinical Innovations
ClinicalTrials.gov Identifier: NCT00893022
  Purpose

The purpose of this study is to test the effects of Otelixizumab for individuals with recently diagnosed diabetes.


Condition Intervention Phase
Diabetes
Drug: Otelixizumab
Drug: Placebo
Phase III

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: A Clinical Study of the Effect of Defend-1 Otelixizumab for Individuals With Recently Diagnosed Diabetes

Further study details as provided by Clinical Innovations:

Primary Outcome Measures:
  • Test the effects of Otelixizumab. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: January 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Otelixizumab: Experimental
Otelixizumab
Drug: Otelixizumab
Otelixizumab
Placebo: Placebo Comparator
Placebo
Drug: Placebo
Placebo

Detailed Description:

The primary objective is to otelixizumab demonstrate that subjects who receive an 8 day series of otelixizumab infusions have greater improvement than subjects who receive placebo in endogenous insulin secretion, as assessed by area under the concentration-time curve (AUC) for mixed meal-stimulated C peptide, at 12 months after study drug administration.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of Type I diabetes with an interval of < 90 days between initial diagnosis and the first dose of study drug.
  • Have a written documentation of the diabetes Mellitus diagnosis, including the date of diagnosis, must be obtained from the diagnosing physician
  • Currently require insulin treatment for Type I Diabetes Mellitus
  • Be willing to remain at the study center for at least 6 hours on each day of dosing (8 consecutive days)
  • BMI < 32

Exclusion Criteria:

  • Have significant systemic infections during the 6 weeks before the first dose of study drug (i.e., infection requiring hospitalization, major surgery, or IV antibiotics to resolve, other infections e.g., bronchitis, sinusitis, localized cellulitis, candidiasis, or urinary tract infection)
  • Have hepatitis
  • Have used any potent immunosuppressive agent (e.g., systemic high-dose corticosteroids on a chronic basis, methotrexate, cyclosporine, or anti-TNF agents) within the 30 days before signing the informed consent and not expected to require such treatment within 3 months after the last dose of study drug
  • Have used any atypical antipsychotic drug within the 30 days before signing informed consent and not expected to require such treatment during the study
  • Have received a vaccine within 30 days before signing informed consent and not expected to require a vaccine during the dosing period or the 14 days after the last dose of study drug
  • Have previously received otelixizumab or any other anti-CD3 monoclonal antibody
  • Have previously received an anti-lymphocyte monoclonal antibody, such as ATG, Rituxan® or Campath®
  • Have undergone any major surgical procedure within 30 days of first dose of study drug
  • Have prior allergic reaction, including anaphylaxis, to any human, humanized, chimeric or rodent antibody
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00893022

Contacts
Contact: David Cohen (866) 478-8391 volunteers@citrials.com

Locations
United States, California
Clinical Innovations Recruiting
Costa Mesa, California, United States, 92626
Contact: David Cohen     866-478-8391     volunteers@citrials.com    
Sponsors and Collaborators
Clinical Innovations
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Innovation ( David Poling )
Study ID Numbers: TRX4_DM_006_NA_06
Study First Received: May 1, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00893022     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Clinical Innovations:
diabetes
tolerx
defend 1
defend-1

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009