Type 1 diabetes Nutritional, Metabolic, Endocrine
Conditions
Interventions
Group 1: Abatacept at weeks 0, 2, 4 and 8 in combination with Interleukin-2 only for 16 weeks starting at week 0
Group 2: Abatacept only at week 0, 2, 4 and 8
Abatacept
Participants will receive 10 m
Sponsors
Cardiff University
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-50 years 2. Diagnosis of Type 1 diabetes in the last 5 years, but not earlier than 3 months 3. Written and witnessed informed consent to participate 4. Detectable non-fasting C-peptide in the blood at screening
Exclusion criteria
Exclusion criteria: 1. Females who are pregnant, breastfeeding, anticipating being pregnant within 14 weeks of the last study drug administration or not using adequate forms of contraception. Males whose partners are WOCBP and not using an adequate form of contraception. 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): 1.1. Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, transdermal 1.2. Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable 1.3. Intrauterine device (IUD) 1.4. Intrauterine hormone-releasing system (IUS) 1.5. Bilateral tubal occlusion 1.6. Vasectomised partner (provided that the partner is the sole sexual partner of the trial participant, and that medical assessment of azoospermia has been confirmed) 1.7. Sexual abstinence (defined as refraining from heterosexual intercourse during the duration of the trial) 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. Immunisations with live vaccines within 1 month from screening 4. Immunodeficient or have clinically significant lymphopaenia 5. Patients with White Blood Count (WBC) 90 mmol/mol measured in the last 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of detecting that the decrease in Treg frequency associated with abatacept treatment in T1D is inhibited by appropriately dosed IL-2 therapy, measured using flow cytometry at Week 20 in comparison to baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactDanijela Tatovic
Outcome results
None listed