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| Tracking Information | |
|---|---|
| First Received Date ICMJE | May 13, 2008 |
| Last Updated Date | March 2, 2010 |
| Start Date ICMJE | May 2008 |
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
Amount of C-peptide (a protein that shows how much insulin the body is producing) during a mixed meal stimulation test. [ Time Frame: at 12 months ] [ Designated as safety issue: No ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00678886 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE |
Average daily insulin use, HbA1c (a measurement of blood glucose control), and incidence of abnormal blood glucose levels. [ Time Frame: at Months 6, 12, 18, and 24 ] [ Designated as safety issue: Yes ] |
| Original Secondary Outcome Measures ICMJE | Same as current |
| Descriptive Information | |
| Brief Title ICMJE | Phase 3 Trial of Otelixizumab for Adults With Newly Diagnosed Type 1 Diabetes Mellitus (Autoimmune): DEFEND-1 |
| Official Title ICMJE | Durable-Response Therapy Evaluation For Early or New-Onset Type 1 Diabetes - DEFEND |
| Brief Summary | To find out if an 8-day series of otelixizumab infusions leads to greater improvement in insulin secretion as compared with placebo. Insulin secretion will be assessed using mixed meal-stimulated C-peptide. Subjects will be assigned to receive either otelixizumab or placebo at a ratio of 2:1 (2/3 otelixizumab, 1/3 placebo). These study agents will be administered as an addition to insulin, diet, and other standard of care treatments. DEFEND-1 is now closed to enrollment. DEFEND-2 will begin early in 2010. It is very similar to DEFEND-1 and will again require subjects with new onset type 1 diabetes. Please check back here for more details. In the meantime, established and new onset type 1 diabetes patients in North America are welcome to consider the TTEDD study: http://www.clinicaltrials.gov/ct2/show/NCT00451321?term=TTEDD&rank=1 |
| Detailed Description | The following visits are required:
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| Study Phase | Phase III |
| Study Type ICMJE | Interventional |
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Condition ICMJE | Type 1 Diabetes Mellitus |
| Intervention ICMJE |
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| Study Arms / Comparison Groups |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Active, not recruiting |
| Estimated Enrollment ICMJE | 240 |
| Completion Date | |
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 12 Years to 45 Years |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada, Denmark, Finland, Germany, Italy, Spain, Sweden, United Kingdom |
| Administrative Information | |
| NCT ID ICMJE | NCT00678886 |
| Responsible Party | Kathleen Osborn/Clinical Study Manager, Tolerx, Inc. |
| Study ID Numbers ICMJE | TRX4006 |
| Study Sponsor ICMJE | Tolerx Inc. |
| Collaborators ICMJE | Juvenile Diabetes Research Foundation |
| Investigators ICMJE | |
| Information Provided By | Tolerx Inc. |
| Verification Date | March 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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