Buccal Spray Insulin for the Management of Post-Prandial Hyperglycaemia in Subjects with Impaired Glucose Tolerance
Abstract Number: 233-OR
Authors: ANDREA PALERMO, PAOLO POZZILLI, NICOLA NAPOLI, FLAVIA COSTANZA, GIUSY BERETTA, SILVIA MANFRINI
Institutions: Rome, Italy
Results: Postprandial hyperglycemia (PPHG) occurs as the consequence of a reduced early insulin response after a meal and has been linked with an increased risk of cardiovascular events and raised mortality risk. Subjects with PPHG often present with dyslipidaemia, hypertension, abdominal obesity, microalbuminuria, endothelial dysfunction and markers of inflammation.
The objective of this phase II study was to investigate the safety and efficacy of treatment with buccal spray insulin (Generex Oral-lyn™) on post-prandial plasma glucose excursions and insulin levels in subjects with impaired glucose tolerance (IGT). A total of 15 Caucasian subjects, mean age 50.1 ±13.7 SD years, 10 females and 5 males with IGT were included in the study. Subjects were randomized to take 4, 6 or 12 Generex Oral-lyn™ puffs, split in two doses each, before and 30 minutes after a standard 75 gr oral glucose tolerance test (OGTT). Glucose excursions and insulin levels were measured at baseline and at 30, 60, 90, 120, 180 min.
There were no significant differences in glucose levels during OGTT with 4 or 6 U.I. doses compared to baseline OGTT. Treatment with 12 Units was followed by a significant 31.2% decrease in mean plasma glucose (mg/dl) at two-hours (from 179.0± 10.9 to 124.0±42.8, p=0.01) and a 28.4% decrease at three-hours (from 126.8±55.1 to 86.5±24.8, p=0.04). Considering all time points of OGTT, there was a mean reduction of 16.5% in plasma glucose levels. There was a trend for increased insulin (µU/L) levels at all measurements reaching statistical significance at 30 min (from 59.6±17.2 to 76.4±18.2, p=0.04). No adverse events were observed during the study period.
In conclusion, this proof of concept study demonstrates that treatment with buccal spray insulin is a simple and valuable therapy for PPHG in subjects with IGT.