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Tracking Information | |||||
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First Received Date ICMJE | March 25, 2008 | ||||
Last Updated Date | June 12, 2012 | ||||
Start Date ICMJE | March 2008 | ||||
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Change in EGR2 expression in PBMCs upon treatment with anakinra in subjects with newly diagnosed type 1 diabetes [ Time Frame: 1 month ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00645840 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Effect size on preservation of C-peptide secretory capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes | ||||
Official Title ICMJE | An Exploratory, Open Label Study of Anti-inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type 1 Diabetes Mellitus | ||||
Brief Summary | The purpose of this study is to determine whether control of inflammatory pathways mediated by IL-1 beta using the IL-1 receptor antagonist anakinra will yield measurable decreases in expression of genes that are otherwise overexpressed as a consequence of IL-1 beta effects in children with newly diagnosed type 1 diabetes. Ultimately, we believe that control of IL-1 beta pathways will be associated with preserved insulin secretory capacity. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Type 1 Diabetes Mellitus | ||||
Intervention ICMJE | Drug: Anakinra
Patients will receive daily anakinra therapy for 28 days
Other Name: Kineret |
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Study Arms | |||||
Publications * | Sumpter KM, Adhikari S, Grishman EK, White PC. Preliminary studies related to anti-interleukin-1? therapy in children with newly diagnosed type 1 diabetes. Pediatr Diabetes. 2011 Apr 24; [Epub ahead of print] | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 15 | ||||
Completion Date | September 2009 | ||||
Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Years to 18 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00645840 | ||||
Other Study ID Numbers ICMJE | UTSW 112007-037 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | University of Texas Southwestern Medical Center | ||||
Study Sponsor ICMJE | University of Texas Southwestern Medical Center | ||||
Collaborators ICMJE | Children's Medical Center Dallas | ||||
Investigators ICMJE |
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Information Provided By | University of Texas Southwestern Medical Center | ||||
Verification Date | June 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |