Type 1 Diabetes Clinical Trial
— INITIIOfficial title:
A Randomised, Double-blind, Placebo-controlled Trial of Intranasal Insulin (440 IU) in Children and Young Adults at Risk of Type 1 Diabetes: Intranasal Insulin Trial II
Verified date | October 2020 |
Source | Melbourne Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In people with type 1 diabetes the beta cells of the pancreas no longer make insulin because the body's immune system has attacked and destroyed the beta cells. It is thought that exposure of the mucous membranes to insulin may cause act like a vaccine effect whereby protective immune cells are stimulated and these then counteract the "bad" immune cells that damage the beta cells. This study aims to determine if intranasal insulin can protect beta cells and stop progression to diabetes in individuals who are at risk.
Status | Completed |
Enrollment | 110 |
Est. completion date | November 13, 2019 |
Est. primary completion date | November 13, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 30 Years |
Eligibility |
Inclusion Criteria: 1. First-degree or second-degree relative of a person with Type 1 diabetes (T1D) diagnosed before age 40. 2. Age 4-30 years if first-degree relative; age 4-20 years if second-degree relative. 3. Confirmed serum antibodies to two or more islet antigens. 4. Normal oral glucose tolerance test (OGTT). 5. 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) 6. Provision of written consent. - Exclusion Criteria: 1. History of treatment with insulin or oral hypoglycemic agents 2. Known diabetes by ADA/WHO criteria 3. Pregnant or lactating or of child-bearing potential not using an adequate method of contraception 4. Concomitant disease or treatment which may interfere with assessment or cause immunosuppression, as judged by the investigators. 5. Uncorrected vitamin D deficiency 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 Aspartate transaminase (AST) or Alanine transaminase (ALT) levels. 8. Impaired renal function 9. Any defect or pathology of nasal passage which would preclude application of the intranasal spray. - |
Country | Name | City | State |
---|---|---|---|
Australia | Mater Children's Hospital | Brisbane | Queensland |
Australia | Royal Melbourne Hospital | Melbourne | Victoria |
Australia | Womens and Childrens Hospital | North Adelaide | South Australia |
Australia | Princess Margaret Hospital | Subiaco | Western Australia |
Australia | The Children's Hospital at Westmead | Westmead | New South Wales |
New Zealand | University of Auckland | Auckland |
Lead Sponsor | Collaborator |
---|---|
Melbourne Health |
Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnosis of Diabetes AT 5 years according to American Diabetes Association / World Health Organization (ADA/WHO) criteria. | Defined as the presence of 2 or more of the following diagnostic criteria including diabetic fasting blood glucose level, diabetic 2 hour postprandial blood glucose level, diabetic HbA1c and symptoms | 1 year of treatment 9 years follow up | |
Secondary | B cell function | Measured as glucose and insulin responses in Oral glucose tolerance test (OGTT) 6 monthly | 1 year of treatment 9 years follow up | |
Secondary | Insulin Action | Insulin resistance measured by Homeostasis of model assessment - resistance (HOMA-R) 6 monthly | 1 year of treatment 9 years follow up | |
Secondary | Immune function | Measured by levels of circulating antibodies to insulin, Glutamic acid decarboxylase (GAD) and Tyrosine phosphatase - like insulinoma antigen (IA-2) and T cell responses to proinsulin, denatured insulin, GAD and tetanus at 5 years | 1 year of treatment 9 years follow up |
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