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Anti-Inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes
This study is enrolling participants by invitation only.
First Received: March 25, 2008   Last Updated: March 27, 2008   History of Changes
Sponsors and Collaborators: University of Texas Southwestern Medical Center
Children's Medical Center Foundation
Information provided by: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00645840
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes Mellitus
Drug: Anakinra
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:

An Exploratory, Open Label Study of Anti-Inflammatory Therapy With Anakinra in Children With Newly Diagnosed Type

1 Diabetes Mellitus


Resource links provided by NLM:


Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Effect size on preservation of C-peptide secretory capacity [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2008
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anakinra
    Patients will receive daily anakinra therapy for 28 days
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645840

Locations
United States, Texas
Children's Medical Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Children's Medical Center Foundation
Investigators
Principal Investigator: Soumya Adhikari, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: UT Southwestern Medical Center ( Soumya Adhikari, MD )
Study ID Numbers: UTSW 112007-037
Study First Received: March 25, 2008
Last Updated: March 27, 2008
ClinicalTrials.gov Identifier: NCT00645840     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas Southwestern Medical Center:
Type 1 diabetes mellitus
IL1 beta
Anakinra

Study placed in the following topic categories:
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases
Diabetes Mellitus Type 1
Interleukin 1 Receptor Antagonist Protein
Endocrinopathy
Antirheumatic Agents
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1
Therapeutic Uses
Diabetes Mellitus
Endocrine System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Glucose Metabolism Disorders
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 10, 2009