Oral insulin (ORMD-0801) in type 2 diabetes mellitus: A dose-finding 12-week randomized placebo-controlled study.

Roy EldorBruce H FrancisAlexander FlemingJoel NeutelKenneth HomerMiriam KidronJulio Rosenstock

Published in: Diabetes, obesity & metabolism (2022)

Oral insulin (ORMD-0801) induced greater reductions in HbA1c when compared to placebo, and was safe and well tolerated in individuals with uncontrolled T2DM. The efficacy and safety findings support continued development of the 8-mg dose at bedtime, which is currently being evaluated in two Phase 3 trials.

Keyphrases

double blind
placebo controlled
type diabetes
glycemic control
phase iii
clinical trial
high glucose
open label
phase ii
diabetic rats
drug induced
adipose tissue
metabolic syndrome
endothelial cells
insulin resistance