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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05160142 -
Diabetes Inspired Culinary Education
|
Early Phase 1 | |
| Withdrawn |
NCT05035368 -
Ladarixin as Adjunctive Therapy to Improve Insulin Sensitivity and Glucometabolic Outcomes in Type 1 Diabetes
|
Phase 2 | |
| Completed |
NCT01928329 -
A Phase II Trial to Examine the Effect of Subcutaneous Exenatide (Bydureon®) on Glucose Control in Patients With Type I Diabetes
|
Phase 2 | |
| Completed |
NCT02127762 -
The Effect of Mindfulness Based Stress Reduction in Patients With Painful Diabetic Peripheral Neuropathy
|
N/A | |
| Completed |
NCT00999375 -
Cultivating Healthy Environments in Families With Type 1 Diabetes (CHEF)
|
Phase 2 | |
| Active, not recruiting |
NCT04279613 -
A Multiple Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0361-0041
|
Phase 1 | |
| Not yet recruiting |
NCT02117518 -
Selective Immunotargeting of Pathogenic CD8 T Cells of Type 1 Diabetes Patients
|
N/A | |
| Terminated |
NCT01308437 -
Immunosafety Study of Recombinant Human Insulins in Type 1 Diabetics
|
Phase 3 | |
| Terminated |
NCT01652911 -
A Phase I/II Study of the Safety and Efficacy of Sernova's Cell PouchTM for Therapeutic Islet Transplantation
|
Phase 1/Phase 2 | |
| Completed |
NCT06242548 -
How Type I Diabetes Responds to Different Diets (Normoglucidic or Ketogenic) During Physical Activity at Altitude
|
N/A | |
| Completed |
NCT00351650 -
Assessment of Beta Cell Mass in Type 1 Diabetes With 11C-Dihydrotetrabenazine and PET Scan
|
N/A | |
| Withdrawn |
NCT00361608 -
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
|
N/A | |
| Terminated |
NCT03653533 -
Evaluation of the Function "Stop Before Hypoglycemia" on External Insulin Pump
|
N/A | |
| Completed |
NCT00340639 -
Management of Type 1 Diabetes Among Adolescents
|
N/A | |
| Completed |
NCT02634216 -
Effects of Capros in Patients With Type-1 Diabetes
|
N/A | |
| Completed |
NCT02002130 -
The Use of Glutamic Acid Decarboxylase (GAD) and Gamma-Amino Butyric Acid (GABA) in the Treatment of Type I Diabetes
|
Phase 1 | |
| Withdrawn |
NCT01623388 -
Epigenetic Modifications of Diabetes Mellitus Type I
|
N/A | |
| Completed |
NCT02612493 -
Obesity and Metabolic Surgery in Patients With Type I Diabetes
|
N/A | |
| Completed |
NCT01843114 -
Measurement of Total Retinal Blood Flow in Patients With Diabetes and Healthy Subjects
|
N/A | |
| Withdrawn |
NCT01398670 -
Immunogenicity Study of Wockhardt's Insulin Lispro/Lispro Mix Basal Bolus Regimen in Type 1 Diabetics
|
Phase 3 |