COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645840
Recruitment Status : Completed
First Posted : March 28, 2008
Results First Posted : November 14, 2019
Last Update Posted : November 14, 2019
Children's Medical Center Dallas
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Anakinra Phase 1 Phase 2

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Anakinra

Arm Intervention/treatment
Experimental: Anakinra
After study enrollment, all subjects started anakinra (Kineret™; Amgen, Thousand Oaks, CA, USA) as a subcutaneous daily injection. Subjects weighing >25 kg at the time of enrollment received 100 mg daily, whereas those weighing <25 kg received 50 mg daily. Anakinra was continued for 28 d with no dose adjustment.
Drug: Anakinra
Patients will receive daily anakinra therapy for 28 days
Other Name: Kineret

Primary Outcome Measures :
  1. Effect of Anakinra Treatment on PBMC Gene Expression for Patients [ Time Frame: 1 month ]
    Expression data at baseline and after treatment were available on 10 patients who had received anakinra. These were compared to similarly-timed samples from 10 patients from control group B. Several attempts have been made to contact the PI to verify information, but were unsuccessful. Unable to verify if 10 or 12 patients were analyzed.

Secondary Outcome Measures :
  1. C-peptide Secretory Capacity [ Time Frame: 7 months ]
    Mixed-meal tolerance tests. MMTTs were conducted at the UT Southwestern Clinical Translational Research Center (CTRC). Subjects underwent MMTTs at 3-4 wk after diagnosis and again at 7 months after diagnosis. C-peptide analyses were performed by Dr Philip Raskin (UTSouthwestern MedicalCenter, Dallas, TX,USA). C-peptide AUC was calculated for each MMTT using the trapezoidal method. C-peptide AUC data between groups were rank transformed and then analyzed using a two-way repeated measures analysis of variance (ANOVA).

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645840

Layout table for location information
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
Layout table for investigator information
Principal Investigator: Soumya Adhikari, MD UT Southwestern Medical Center
Publications of Results:
Layout table for additonal information
Responsible Party: University of Texas Southwestern Medical Center Identifier: NCT00645840    
Other Study ID Numbers: UTSW 112007-037
First Posted: March 28, 2008    Key Record Dates
Results First Posted: November 14, 2019
Last Update Posted: November 14, 2019
Last Verified: October 2019
Keywords provided by University of Texas Southwestern Medical Center:
Type 1 diabetes mellitus
IL1 beta
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents