Combination immunotherapy for children and young adults with recently-diagnosed type 1 diabetes

Phase 2

• Conditions: Type 1 diabetes; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12622001236785
• Lead Sponsor: Melbourne Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-09-13
• Last Update Posted: 10 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Age between 6 and 21 years and weight>20kg at Screening Visit; diabetes mellitus diagnosed within 100 days of first dose of study drugs; presence of at least one islet autoantibody; random C-peptide >0.3nmol/l; using CGM and willing to do this for the duration of the study; demonstrated ability to record home glucose and insulin doses; willing to forego other forms of experimental treatment during the study; up to date with recommended vaccinations; willing to postpone live vaccine immunisations for 3 months after end of treatment.

Exclusion Criteria

Clinical or laboratory evidence of active infection other than localised skin infection; immunodeficiency or chronic use of immunosuppressive drugs other than topical or inhaled glucocorticoid; vaccination with live or dead virus within 4 weeks of the first dose of study drugs; history of malignancy; pregnant or lactating, or of child-bearing potential not using an effective method of contraception; any pathology of the nasal passages that would contraindicate nasal spray treatment; any condition that would interfere with study conduct or participant safety

Study & Design

• Study Type: Interventional
• Study Design: Not specified