Phase 2
N=15
Anti-inflammatory Therapy With Anakinra in Newly Diagnosed Type 1 Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT00645840 ↗Enrolled (actual)
15
Serious AEs
8.3%
Results posted
Nov 2019
Primary outcome: Primary: Effect of Anakinra Treatment on PBMC Gene Expression for Patients — 0 probe sets
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Anakinra (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Anakinra Treatment on PBMC Gene Expression for Patients |
— | — |
| SECONDARY C-peptide Secretory Capacity |
160.5 | — |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00645840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.