Type-1-Diabetes
Conditions
Interventions
Product Name: human insulin
Product Code: DV001 (Human recombinant Insulin formulation)
Pharmaceutical Form: Nasal spray
INN or Proposed INN: intranasal insulin
Current Sponsor code: DV001
Other descr
Sponsors
Melbourne Health, Royal Melbourne Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. First-degree or 2nd-degree relative of person with T1D diagnosed before age 40; 2. Age 4-30 years if 1st-degree relative Age 4-20 years if 2nd-degree-relative 3. Confirmed serum antibodies to 2 or more islet antigens 4. Normal OGTT 5. FPIR at or above threshold - Primary Stratum: = 10th percentile for siblings, offspring and second-degree relatives of someone with T1D (= 100uU/ml if aged = 8 years or = 60uU/ml if aged =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1. History of treatment with insulin or oral hypoglycaemic agents 2. Known diabetes by ADA/WHO criteria (fasting plasma glucose ³7mM or 2 hour plasma glucose in the OGTT ³ 11.1mM). 3. Pregnant or lactating, or of child-bearing potential not using a highly effective method of contraception (failure rate <1% per year when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner). 4. Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators. 5. Uncorrected vitamin D deficiency (serum 25OHD <50nM). 6. Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance. 7. Known liver disease, or persisting elevation of plasma AST (³ 100 IU/L) or ALT (³ 110 IU/L) levels. 8. Impaired renal function (serum creatinine ³ 110uM in females or ³ 130uM in males). 9. Any defect or pathology of nasal passage which would preclude application of the intranasal spray.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of this study is to determine whether intranasal administration of insulin to young children and adults at risk for type 1 diabetes (T1D) will reduce their rate of development of diabetes.;Secondary Objective: Secondary objective is to determine whether intranasal insulin administration to children and young adults at risk for T1D will: 1) prevent expected loss of pancreatic ß-cell function 2) improve insulin action 3) stimulate immune responses consistent with the induction of immune tolerance to insulin;Primary end point(s): The onset of diabetes, defined by ADA/WHO criteria;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108 and 120 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): B-cell function assessed by the glucose and insulin responses in the OGTT Insulin resistance assessed by HOMA-R Iselt autoantibody levels and T cell responses to islet autoantigens;Timepoint(s) of evaluation of this end point: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 72, 84, 96, 108 and 120 months | — |
Countries
Australia, Germany, New Zealand
Contacts
Public ContactINIT II Project Manager
Melbourne Health, Royal Melbourne Hospital
Outcome results
None listed