Phase 1b study of proinsulin (PI) peptide immunotherapy in new onset type 1 diabetes

Phase 1

Completed

• Conditions: ewly diagnosed type 1 diabetes; Nutritional, Metabolic, Endocrine; Insulin-dependent diabetes mellitus

• Registration Number: ISRCTN66760879
• Lead Sponsor: Cardiff University

Brief Summary

1. 2017 results in https://www.ncbi.nlm.nih.gov/pubmed/28794283 (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-07-28
• Study Completion: 2015-02-16
• Last Update Posted: 21 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Age 18-40 years
2. Diagnosis of Type 1 diabetes within the last 100 days (dated from the first insulin injection)
3. Possession of HLA-DRB1*04:01 allele
4. At least one positive islet cell autoantibody (ie anti-GAD65, antibodies to insulinoma-associated antigen-2 (IA-2) or zinc transporter 8 (ZnT8)).
5. Peak insulin C-peptide >200 pmol/L (at any time point after stimulation with Mixed Meal Tolerance Test)
6. Written and witnessed informed consent to participate

Exclusion Criteria

1. Females who are pregnant, breast-feeding or not using adequate forms of contraception
2. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomisation and any monoclonal antibody therapy given for any indication
3. Any other medical condition which, in the opinion of investigators, could affect the safety of the subject's participation
4. Recent subject's involvement in other research studies which, in the opinion of investigators, may adversely affect the safety of the subjects or the results of the study
5. Subjects should not have had immunisations with live or killed vaccines or allergic desensitisation procedures less than 1 month prior to their first treatment

Study & Design

• Study Type: Interventional
• Study Design: Not specified