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Sponsored by: |
Clinical Innovations |
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Information provided by: | Clinical Innovations |
ClinicalTrials.gov Identifier: | NCT00893022 |
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 |
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 |
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
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Drug: Otelixizumab
Otelixizumab
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
Placebo
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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.
Ages Eligible for Study: | 18 Years to 35 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Cohen | (866) 478-8391 | volunteers@citrials.com |
United States, California | |
Clinical Innovations | Recruiting |
Costa Mesa, California, United States, 92626 | |
Contact: David Cohen 866-478-8391 volunteers@citrials.com |
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 |
diabetes tolerx defend 1 defend-1 |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |