The Effect of Food Intake on the Pharmacokinetics of Oral Basal Insulin: A Randomised Crossover Trial in Healthy Male Subjects.

ABSTRACT:

Background

Oral insulin 338 is a novel tablet formulation of a long-acting basal insulin. This randomised, open-label, four-period crossover trial investigated the effect of timing of food intake on the single-dose pharmacokinetic properties of oral insulin 338.

Methods

After an overnight fast, 44 healthy males received single fixed doses of oral insulin 338 administered 0, 30, 60 or 360 min before consuming a standardised meal (500 kcal, 57 energy percent [E%] carbohydrate, 13 E% fat, 30 E% protein). Blood samples for pharmacokinetic assessment were taken up to 288 h post-dose.

Results

Total exposure (area under the concentration-time curve from time zero to infinity [AUC_Ins338,0-∞]) and maximum concentration (C_max,Ins338) of insulin 338 were bo

SUBMITTER: Halberg IB 

PROVIDER: S-EPMC6856260 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature