Trial of Intranasal Insulin in Children and Young Adults at Risk of Type 1 Diabetes (INITII)
Type 1 Diabetes
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 diabetes
Eligibility Criteria
Inclusion Criteria: First-degree or second-degree relative of a person with Type 1 diabetes (T1D) diagnosed before age 40. Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative. Confirmed serum antibodies to two or more islet antigens. Normal oral glucose tolerance test (OGTT). First phase insulin response (FPIR) at or above threshold - Primary Stratum - greater than or equal to 10th percentile for siblings, offspring and second-degree relatives of person with T1D (greater than or equal to 100uU/ml if aged 8 or more years OR greater than or equal to 60 uU/ml if aged less than 8) and greater than or equal to the 1st percentile for parents of someone with T1D (greater than ore equal to 60uU/ml). Secondary Stratum: Greater than or equal 1st percentile, less than 10th percentile for siblings, offspring and second-degree relatives of someone with T1D (greater than or equal to 50uU/ml less than 100 uU/ml if aged greater than or equal to 8 years or greater than or equal to 20 uU/ml less than 60uU/ml if aged less than 8 years) Provision of written consent. - Exclusion Criteria: History of treatment with insulin or oral hypoglycemic agents Known diabetes by ADA/WHO criteria Pregnant or lactating or of child-bearing potential not using an adequate method of contraception Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators. Uncorrected vitamin D deficiency Known alcohol or drug abuse, psychiatric or other condition that could be associated with poor compliance. Known liver disease, or persisting elevation of plasma Aspartate transaminase (AST) or Alanine transaminase (ALT) levels. Impaired renal function Any defect or pathology of nasal passage which would preclude application of the intranasal spray. -
Sites / Locations
- The Children's Hospital at Westmead
- Mater Children's Hospital
- Womens and Childrens Hospital
- Royal Melbourne Hospital
- Princess Margaret Hospital
- University of Auckland
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
DV001
Placebo
Recombinant human intranasal insulin formulation in a buffered solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product is formulated at a dose strength of 1100 IU / mL (40mg/mL) manufacturing formulation. The product will be self administered by eligible participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.
Placebo insulin carrier solution of benzalkonium chloride and glycerol presented in multi-dose nasal spray devices with actuators (Pfeiffer) designed to deliver 100ul spray doses to nasal mucosa. The product will be self administered by participants as two 100 microlitre spray doses per nostril. Treatment will be administered daily for 7 consecutive days then on one day each week for 12 months. Participants will be followed until they develop diabetes or until 5 years after the last participant has been randomised (maximum period of follow up is expected to be 10 years.