Type I Diabetes Clinical Trial
Official title:
Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes.
This is a randomized, double-blind, placebo-controlled phase 2 study. Specific aim is to evaluate feasibility and safety of anti-IL-1 (interleukin 1) treatment in the course of standard therapy for diabetic ketoacidosis in children and its effect on intracranial pressure.
Anakinra is a fully human IL-1ra (interleukin 1 receptor agonist) licensed in 2001 by FDA for
the treatment of rheumatoid arthritis. It competitively binds to the IL-1 receptor, thus
blocking IL-1 signaling. It is a short-acting agent that requires daily subcutaneous
administration at 1-2 mg/kg, maximum 100 mg/dose. It has been effective in lowering HbA1c
(glycated haemoglobin) in T2D (type 2 diabetes) and a randomized trial of anakinra in recent
onset T1D (type 1 diabetes) is underway in Europe. Overall, anakinra has been used in adults
and children with a good safety record, for more than 10 years. Infrequent side effects
include infections, neutropenia, nausea, diarrhea, cardiopulmonary arrest, influenza-like
symptoms, and production of anti-anakinra antibodies.
Study Design: A double-blinded placebo-controlled RCT (randomized controlled trial) with 2:1
allocation (14 active treatment vs. 7 placebo). Anakinra treatment will be given as a bolus
of 2 mg/kg infused intravenously over 30 minutes followed by infusion of 2 mg/kg/hour for 4
hours immediately after confirmation of the diagnosis of DKA (diabetic keto-acidosis) and
when laboratory safety parameters are available (CBC (complete blood count) and pregnancy
test) and after a consent is obtained. Primary outcomes: Safety and tolerability of anti-IL-1
treatment (anakinra) during the initial 24 hr period of DKA treatment. Secondary outcomes:
Optic nerve sheath diameter (cut-off to define cerebral edema: 4.5 mm); Changes in cytokines
levels during the treatment with anakinra.
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