Anti-IL-1 Treatment in Children Diabetic Keto-Acidosis (DKA) at Diagnosis of Type 1 Diabetes

NCT01477476 | Withdrawn Phase 2 DMC

• 2 other identifiers: 11-0814P30DK057516
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type I Diabetes

Keywords

DKA; Diabetes; Type I Diabetes

Outcome Measures

Primary Outcomes (1)

• Frequency of Adverse Events

  Type and number of Adverse Events related to anti-IL-1 treatment (anakinra) during the initial 24 hour period of DKA treatment.

  24 hours

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

14 subjects with receive active treatment with Anakinra.

Drug: Anakinra

Placebo

PLACEBO COMPARATOR

7 subjects will receive the placebo comparator.

Other: Placebo Comparator

Interventions

Anakinra 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.

Also known as: anti Interleukin 1 receptor antibodies

Active Treatment

Placebo Comparator OTHER

A placebo will be given to 7 subjects.

Placebo

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

University of Colorado, Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (42)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Arleta Rewers, MD, Phd

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2011
• First Posted: November 22, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: April 22, 2016
• Last Updated: April 18, 2019

Record last verified: 2019-04

Locations

US (2)