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

This study has been completed.
Sponsor:
Collaborator:
Children's Medical Center Dallas
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00645840
First received: March 25, 2008
Last updated: June 12, 2012
Last verified: June 2010
  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 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 15
Study Start Date: March 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Anakinra
    Patients will receive daily anakinra therapy for 28 days
    Other Name: Kineret
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Dallas
Investigators
Principal Investigator: Soumya Adhikari, MD UT Southwestern Medical Center
  More Information

Publications:
Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00645840     History of Changes
Other Study ID Numbers: UTSW 112007-037
Study First Received: March 25, 2008
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014