Safety Study to Assess Whether Proinsulin Peptide Injections Can Slow or Stop the Body Damaging Its Own Insulin-making Cells in the Pancreas in Patients Newly Diagnosed With Type 1 Diabetes

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to address the safety issue of whether, in patients with newly-diagnosed diabetes who still make some insulin, proinsulin peptide therapy adversely affects the rate of damage to the insulin making cells.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiff University
• Collaborators: Diabetes Vaccine Development Centre; Juvenile Diabetes Research Foundation
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

1. Age 18-40 years.

2. If female, must be (as documented in patient notes):

• postmenopausal (at least 1 year without spontaneous menses)

• surgically sterile (tubal ligation or hysterectomy at least 6 months prior to enrolment)

• using acceptable contraception (e.g., oral, intramuscular, or implanted hormonal contraception) at least 3 months prior to enrolment

• have a sexual partner with non-reversed vasectomy (with confirmed azoospermia)

• be using 1 barrier method with the use of a spermicide(e.g., condom, diaphragm or cap)

• have placement of a intra-uterine device

3. If male, must be:

• using a barrier method of contraception (condom) with the use of a spermicide

• have a sexual partner using one of the methods in point 2 above or

• have a non-reversed vasectomy (with confirmed azoospermia),

4. Diagnosis of Type 1 diabetes within the last 100 days (dated from the first insulin injection).

5. Possession of *0401 allele at the HLA-DRB1 gene locus

6. At least one positive islet cell autoantibody (ie anti-GAD65, antibodies to insulinoma-associated antigen-2 (IA-2) or zinc transporter 8 (ZnT8)).

7. Peak insulin C-peptide >200 pmol/L (at any time point after stimulation with Mixed Meal Tolerance Test).

8. 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.