The Effect of ENDUR-AMIDE® on Type 1 Diabetes Prevention in School Children: An 8-Year Study
Highlights
- ENDUR-AMIDE® may help delay the onset of type 1 diabetes in young children.
- Treatment dosage was 500 mg, twice daily
- Excellent compliance (over 90%) with treatment
Summary
This clinical trial was conducted to evaluate the potential value of ENDUR-AMIDE® wax matrix niacinamide in helping to delay type 1 diabetes in at-risk children.
For this study, researchers at the University of Auckland and others obtained ethical approval to test over 20,219 school-aged children between the ages of 5 to 7 years – about half the children of this age in Auckland at the time – over a three-year period for the presence of islet cell antibodies (ICA) in the blood. ICA in the blood is reported to be a marker for risk of developing insulin-dependent diabetes. Its predictive value is highest at higher levels of blood ICA and at younger ages. ICA-positive individuals who also have impaired first phase insulin release (FPIR) – an indicator of functional damage to pancreatic islet beta cells – are at even higher risk of developing diabetes.
From this pool of 20,219 children, 158 were identified as eligible for treatment based on elevated blood ICA levels with or without FPIR. Parental consent was obtained for 151 children who were subsequently treated with ENDUR-AMIDE® (500mg, twice daily). Treatment was planned for up to 8 years until either blood ICA disappeared or a diagnosis of diabetes. A group of over 60,900 children, aged 5 to 7 years at any time during the three-year recruitment period, served as an untreated comparison group.
Of the 151 children receiving ENDUR-AMIDE® therapy, 16% (24/151) were followed up for 1.5 years or longer and retested for ICA levels. Results indicate that ICA levels declined in 79% (19/24) of these cases with no cases of increased ICA levels. Excellent treatment compliance (over 90%) was reported, as measure by prescription requests and urinary n-methylnicotinamide. Of the over 60,900 children in the comparison group, a total of 45 developed diabetes over the period of the study. By contrast, none of the 20,219 children in the tested/treated group developed diabetes.
These finding suggest that ENDUR-AMIDe® may have clinical value in helping to delay the onset of type 1 diabetes in young school-aged children.
