Enhanced epidermal antigen specific immunotherapy trial - Type 1 Diabetes

Phase 1

Completed

• Conditions: Type 1 diabetes; Nutritional, Metabolic, Endocrine; Type 1 diabetes mellitus

• Registration Number: ISRCTN16067611
• Lead Sponsor: Cardiff University (UK)

Brief Summary

2022 Results article in https://doi.org/10.1093/immadv/ltac002 (added 20/06/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-06
• Study Completion: 2019-12-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Clinical diagnosis of type 1 diabetes for > 3 months (dated from the first insulin injection)
2. Commenced on insulin treatment within 1 month of diagnosis
3. Age 16 to 40 years
4. 2 hour post-meal UCPCR > 0.53 nmol/mmol on at least one occasion (maximum 3 tests on different days)
5. Possession of 0401 allele at the HLA-DRB1 gene locus
6. The following birth control methods should be used (considered highly effective with a failure rate of less than 1% per year when used consistently and correctly):
6.1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
6.1.1. Oral
6.1.2. Intravaginal
6.1.3. Transdermal
6.2. Progestogen-only hormonal contraception associated with inhibition of ovulation:
6.2.1. Oral
6.2.2. Injectable
6.2.3. Implantable
6.3. Intrauterine device (IUD)
6.4. Intrauterine hormone-releasing system ( IUS)
6.5. Bilateral tubal occlusion
6.6. Vasectomised partner (provided that the partner is the sole sexual partner of the trial participant and that medical assessment of azoospermia has been confirmed)
6.7. Sexual abstinence (defined as refraining from heterosexual intercourse during the duration of the trial)
7. Written and witnessed informed consent to participate

Exclusion Criteria

1. HbA1c > 86mmol/L (10%)
2. Females who are pregnant, breastfeeding or not using adequate forms of contraception
3. Previous diagnosis of renal disease including glomerulonephritis or nephropathy
4. Raised serum creatinine or abnormal urine albumin/creatinine ratio (ACR) (values above the laboratory reference range). If the initial ACR is raised, this should be repeated on two further occasions as first morning samples. The subject can be included if both of these samples are negative (within the reference range)
5. Use of immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to receiving the IMP and any monoclonal antibody therapy given for any indication. Note that previous exposure to proinsulin peptide C19-A3 in a clinical trial is an exclusion criterion
6. Use of cannabis within one month prior to trial entry
7. Use of any hypoglycaemia agents other than insulin, for more than 6 weeks, at any time prior to trial entry
8. Use of inhaled insulin
9. Known alcohol abuse, drug abuse, HIV or hepatitis
10. Allergies to drug components or any excipients
11. Any other medical condition which, in the opinion of investigators, could affect the safety of the subject’s participation or outcomes of the study, including immunocompromised states and autoimmune conditions
12. Subjects should not have had immunisations (flu and others) for 1 month prior to trial entry and should not receive any during their time in the trial – see section 5.6
13. 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
14. Abnormal ECG findings

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety (adverse event) profile of the investigational agent. The following time points are set for evaluation of adverse event profiles, but pharmacovigilance data will be collected at times points in between if events arise: 2 hours, 4 weeks, 8 weeks and 14 weeks