Table 1

Primary or secondary prevention trials prior to clinical diagnosis of diabetes

Study (ref.)Drug/phaseSponsor/contactAgeEligibilityDosingPlaceboFollow-up duration/primary end pointStatus/target size
TRIGR (23)Cow's milk hydrolyzate/phase IIINIH, NICHD, et al./www.trigr.org0–7 daysFDRs, high-risk HLASupplementation of breast-feeding up to the age of 8 monthsYes10 years/type 1 diabetesEnrollment closed/n = 2,160
BABY DIET (24)Gluten-free diet/phase II pilotGerman Research Foundation/anziegler@lrz.uni-munchen.de<3 monthsRelatives, high-risk HLA DR, DQGluten-free diet until age 12 monthsNo3 years/islet autoantibodiesEnrollment closed/n = 50
TrialNet NIP (27)DHA/phase II pilotNIH, NIDDK/www.diabetestrialnet.org>24 weeks gestation/newbornRelatives, HLA-DR3 or DR4Oral DHA once dailyYes2 years/20% higher plasma levels of DHAEnrollment closed/n = 119
Vitamin D (31,82)Vitamin D3/phase I pilotCanadian Diabetes Association/dcatte@mich.ca0–4 weeksHigh-risk HLA DR, DQOral vitamin D 2,000 IU once dailyNo1 year/25(OH) vitamin D levels, serum/urine Ca, islet autoantibodiesEnrolling/n = 20
TrialNet Oral Insulin (33)Human insulin/phase IIINIH, NIDDK/www.diabetestrialnet.org1–45 yearsRelatives, 2+ islet antibodies including to insulinOral insulin 7.5 mg once dailyYes7–8 years/type 1 diabetesEnrolling/n ≈ 400
INIT II (34)Human insulin/phase IIMelbourne Health/harrison@wehi.edu.au4–30 yearsRelatives, 2+ islet antibodies HLA not DR2, DQ6Intranasal 1.6 mg and 16 mg/dayYes5 years/type 1 diabetesEnrolling/n = 262
Pre-POINT (26)Human insulin/phase I/IIJDRF/prevent.diabetes@crt-dresden.de1.5–7 yearsFDRs/>50% risk of type 1 diabetesInsulin daily for the first 10 days, after that twice a week. Increasing dose: oral 2.5–67.5 mg/day, intranasal 0.28–7.5 mg/day*Yes3–18 months/islet autoantibodiesEnrolling/n = 40
FINDIAInsulin-free whey-based formula/phase I/IINational Public Health Institute, Helsinki, Finland/outi.vaarala@ktl.fiInfantsGeneral population, high-risk HLA DQYes2 years/islet autoantibodies, type 1 diabetesEnrollment closed/n = 982
  • *Staggered enrollment. DHA, docosahexaenoic acid; FDR, first-degree relative; JDRF, Juvenile Diabetes Research Foundation; NICHD, National Institute of Child Health and Human Development; NIDDK, National Institute of Diabetes and Digestive and Kidney Diseases; NIH, National Institutes of Health; NIP, Nutritional Intervention to Prevent type 1 diabetes.