Monopeptide Follow-up
Research type
Research Study
Full title
Assessing daily insulin usage and glycated haemoglobin over 2 years following end of follow up period in phase 1b study of proinsulin peptide immunotherapy in new-onset type 1 diabetes
IRAS ID
213140
Contact name
Colin Dayan
Contact email
Sponsor organisation
Cardiff University
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
This study aims to assess the total daily insulin use and the average glucose levels (HbA1c) in patients with type 1 diabetes who took part in the MonoPepT1De-1b study (Phase 1b Study of Proinsulin (PI) Peptide Immunotherapy in New-Onset Type 1 Diabetes) over a period of 2 years following end of participation in this study.
Using available data in the diabetes care services where recruited patients receive their standard diabetes care, values of both total daily insulin usage and HbA1c will be collected and added to the previously available data which was generated from the MonoPepT1De-1b study (conducted by the diabetes research groups at Cardiff University School of Medicine and Kings College London between January 2012 and April 2015). Guided by relevant data analysis from the MonoPepT1De-1b study, findings from this study will be used to assess and confirm any sustainability in the favourable effects which were observed in the patients who received treatment with the naturally processed proinsulin peptide C19-A3 (PI C19-A3) at a dose of 10μg every 14 days or every 28 days for a total of 12 and 6 doses respectively.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0498
Date of REC Opinion
8 Dec 2016
REC opinion
Favourable Opinion