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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66760879

Enrollment

Registered

2011-07-28

Start date

2012-02-14

Completion date

Unknown

Last updated

2020-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Newly diagnosed type 1 diabetes Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

1. Study drug will be administered intradermally at a frequency of either bi-weekly or 4 times a week 2. To maintain blinding, all subjects will receive injections at bi-weekly interva

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Assessment of the safety of PPI C19-A3 peptide administration in subjects with new-onset Type 1 diabetes	—

Secondary

Measure	Time frame
1. Change in stimulated C-peptide production at 12, 24, 36 and 48 weeks versus baseline and between groups 2. Change in level or quality of T lymphocyte biomarkers of alpha cell specific immune response at 12, 24, 36 and 48 weeks versus baseline and between groups 3. Change in level or quality of islet cell autoantibody biomarkers of alpha-cell specific immune response at 12, 24, 36 and 48 weeks versus baseline and between groups 4. Change in glycated haemoglobin (as measured by % HbA1c levels), daily insulin usage, and mean amplitude of glucose excursions at 12, 24, 36 and 48 weeks versus baseline and between groups 5. Changes in the Hypoglycaemia Fear Survey (HFS), and Diabetes Treatment Satisfaction Questionnaire (DTSQs) scores at 3,6 and 12 months and ADDQoL (Audit of Diabetes-Dependent Quality of Life) at 6, and 12 months versus baseline and between groups 6. The DTSQc (Diabetes Treatment Satisfaction Questionnaire, change version) will also be compared between groups at 12 months	—

Measure

Time frame

1. Change in stimulated C-peptide production at 12, 24, 36 and 48 weeks versus baseline and between groups 2. Change in level or quality of T lymphocyte biomarkers of alpha cell specific immune response at 12, 24, 36 and 48 weeks versus baseline and between groups 3. Change in level or quality of islet cell autoantibody biomarkers of alpha-cell specific immune response at 12, 24, 36 and 48 weeks versus baseline and between groups 4. Change in glycated haemoglobin (as measured by % HbA1c levels), daily insulin usage, and mean amplitude of glucose excursions at 12, 24, 36 and 48 weeks versus baseline and between groups 5. Changes in the Hypoglycaemia Fear Survey (HFS), and Diabetes Treatment Satisfaction Questionnaire (DTSQs) scores at 3,6 and 12 months and ADDQoL (Audit of Diabetes-Dependent Quality of Life) at 6, and 12 months versus baseline and between groups 6. The DTSQc (Diabetes Treatment Satisfaction Questionnaire, change version) will also be compared between groups at 12 months

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026