Oral insulin (OI) slows insulin decline in those at high risk for type 1 diabetes (T1D), according to a poster session at the American Diabetes Association’s (ADA) virtual 80th Scientific Session.

The researchers wanted to assess whether OI metabolic declines after 1 year of treatment among highest risk relatives who participated in the Diabetes Prevention Trial-Type 1 (DPT1) and TrialNet (TN) T1D prevention trials for OI. With a diagnosis of T1D as the endpoint, both OI trials were negative overall, yet the subgroup analyses suggested efficacy for those at high risk in each trial, according to the study authors.

The slowed metabolic decline among the OI trial participants at highest risk was assessed and defined by the DPT1 Risk Scores over a 6.75 threshold (DPTRS; oral glucose tolerance test [OGTT] C-peptide and glucose, age, and BMI), above which T1D risk increases sharply as DPTRS increases.

Of 73% in DPT1 and 89% in TN with 1-year OGTTs, 32% in DPT1, and 35% in TN were in the highest risk groups. The area under the curve (AUC) C-peptide increased from baseline to 1 year in both OI groups, but not in the placebo groups, while AUC glucose increased more in the placebo groups than in the OI groups, according to study authors.

In both trials, the 1-year AUC C-peptide/AUC glucose ratio was greater in the OI group than in the placebo group. For DPT1 and TN combined, or no interaction for treatment between trials, the p-value for the AUC ratio difference was <0.001. of those with DPTRS <6.75, the AUC ratio did not differ between OI and placebo.


Sosenko J, Palmer JP, Haller M, et al. Slowed Metabolic Decline after Oral Insulin (OI) in Relatives at High Risk for Type 1 Diabetes (T1D). American Diabetes Association: 80th Scientific Sessions: A Virtual Experience, June 12-16, 2020. https://plan.core-apps.com/tristar_ada20/abstract/f03e8c97-e04b-4e2d-aa97-202e2e13cb1e.