Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: Children's Medical Center Dallas
• Treatments: Anti-Inflammatory Agents; Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Newly diagnosed type 1 diabetes (by ADA criteria) within 1 week of diagnosis.

• Age 6-18 years.

• Males and females will be recruited.

• Subjects and families must be English and/or Spanish-speaking.

Exclusion Criteria:

• Patients with other autoimmune conditions or any other condition (including asthma) necessitating treatment with systemic or inhaled corticosteroids or chronic NSAIDs. Patients cannot have received such therapy in the three months prior to enrollment. Hashimoto's thyroiditis is not an exclusion criterion.

• Patients with active bacterial infections must be cured prior to entry into the study protocol.

• Serum creatinine > 1.5 mg/dL or greater than 1.5x the upper limit of normal for age

• Serum ALT or AST > 3 times the upper limit of normal for the lab

• Platelet count < 100,000/mm3

• WBC count < 3,000 cells/mm3

• Hemoglobin, Hematocrit or Red blood cell count outside 30% of the upper or lower limits of normal for the lab

• Any medication that, in the opinion of the investigator, is being administered for immunomodulatory purposes, including but not limited to systemic or inhaled corticosteroids and chronic NSAIDs

• Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit

• Treatment in the past with anakinra

• Patients with known hypersensitivity to E. coli-derived proteins, anakinra, or any components of anakinra.

• Must not have received immunosuppressive agents (including systemic or inhaled corticosteroids and scheduled/chronic NSAIDs) for at least three months prior to enrollment

• Known HIV-positive status or known history of any other immunodeficiency state.

• Any mycobacterial disease

• Active severe infections within 4 weeks before screening visit, or between the screening and baseline visits.

• Severe comorbidities (congestive heart failure of any severity, myocardial infarction, cerebrovascular accident or transient ischemic attack within 3 months of screening visit, unstable angina pectoris, uncontrolled hypertension (sitting systolic BP <80 mm Hg or > 160 or diastolic BP > 100 mm Hg), oxygen-dependent severe pulmonary disease, history of cancer within 5 years [other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer])

• History of tuberculosis or tuberculosis exposure, chronic hepatitis B or hepatitis C, or systemic lupus erythematosus.

• Pregnant or lactating females

• Use of a live vaccine 90 days prior to, or during this study

• Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient

• History of non-compliance with other therapies