Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes
NCT ID: NCT01477476
Last Updated: 2019-04-18
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
PHASE2
Study Classification
INTERVENTIONAL
Study Start Date
2012-03-31
Study Completion Date
2016-04-22
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Type I Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Active Treatment
14 subjects with receive active treatment with Anakinra.
Group Type
ACTIVE_COMPARATOR
Anakinra
Intervention Type
DRUG
Anakinra treatment will be given I.V. as a bolus of 2 mg/kg infused intravenously over 30 minutes followed by infusion of 2 mg/kg/hour for 4 hours.
Placebo
7 subjects will receive the placebo comparator.
Group Type
PLACEBO_COMPARATOR
Placebo Comparator
Intervention Type
OTHER
A placebo will be given to 7 subjects.
Interventions
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Anakinra
Anakinra treatment will be given I.V. as a bolus of 2 mg/kg infused intravenously over 30 minutes followed by infusion of 2 mg/kg/hour for 4 hours.
Intervention Type
DRUG
Placebo Comparator
A placebo will be given to 7 subjects.
Intervention Type
OTHER
Other Intervention Names
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anti Interleukin 1 receptor antibodies
Eligibility Criteria
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Inclusion Criteria
* Age 8-18 years at diagnosis of type 1 diabetes
* Diabetic ketoacidosis with:
* plasma glucose concentration \>300 mg/dl,
* venous pH \<7.30 or
* serum bicarbonate concentration \<15 mmol/L, and
* ketones in urine or serum
* Hematology:
* WBC \>3000 x 109/L;
* platelets \>100,000 x 109/L;
* hemoglobin \>10.0 g/dL
* Negative blood pregnancy test in females.
* Diabetic ketoacidosis with:
* plasma glucose concentration \>300 mg/dl,
* venous pH \<7.30 or
* serum bicarbonate concentration \<15 mmol/L, and
* ketones in urine or serum
* Hematology:
* WBC \>3000 x 109/L;
* platelets \>100,000 x 109/L;
* hemoglobin \>10.0 g/dL
* Negative blood pregnancy test in females.
Exclusion Criteria
* Children with underlying disorders, including:
* active autoimmune or immune deficiency disorder other than type 1 diabetes,
* malignancy,
* organ transplant,
* any condition requiring chronic corticosteroid use
* Previous immunotherapy to prevent type 1 diabetes
* Current or prior infection with HIV, hepatitis B or hepatitis C assessed by history
* Patients who present with DKA concomitant with alcohol or drug use,
* Head trauma,
* Meningitis or other conditions which might affect neurological function
* Renal failure
* Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject's participation
* Patients with a history of known hypersensitivity to:
* E coli-derived proteins,
* anakinra, or
* any components of the investigational drug product
* active autoimmune or immune deficiency disorder other than type 1 diabetes,
* malignancy,
* organ transplant,
* any condition requiring chronic corticosteroid use
* Previous immunotherapy to prevent type 1 diabetes
* Current or prior infection with HIV, hepatitis B or hepatitis C assessed by history
* Patients who present with DKA concomitant with alcohol or drug use,
* Head trauma,
* Meningitis or other conditions which might affect neurological function
* Renal failure
* Any condition, medical or otherwise that would, in the opinion of the investigator, prevent complete participation in the study, or that would pose a significant hazard to the subject's participation
* Patients with a history of known hypersensitivity to:
* E coli-derived proteins,
* anakinra, or
* any components of the investigational drug product
Minimum Eligible Age
8 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Arleta Rewers, MD, Phd
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Childrens Hospital Colorado
Aurora, Colorado, United States
Site Status
University of Colorado, Anschutz Medical Campus
Aurora, Colorado, United States
Site Status
Countries
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United States
References
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Other Identifiers
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11-0814
Identifier Type: -
Identifier Source: org_study_id
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