Buccal spray insulin in subjects with impaired glucose tolerance: the prevoral study

Aim: Postprandial hyperglycaemia is a consequence of reduced first phase insulin response and is associated with increased cardiovascular risk and mortality. The aim of this proof-of-concept study was to investigate the safety and efficacy of treatment with buccal spray insulin (Oral-lyn (TM), Generex Biotechnology Corporation, Toronto, Ontario, Canada) on postprandial plasma glucose and insulin levels in subjects with impaired glucose tolerance (IGT). Methods: A total of 19 female and 12 male Caucasian subjects, 52.2 +/- 13.5 (SD) years old, having a body mass index of 33.1 +/- 6 (SD) kg/m(2) with confirmed IGT were included in the study. Subjects were randomized to take 4, 6 or 12 Oral-lyn puffs (1 puff = 1 s.c. rapid insulin UI) split into two equal doses each, one before and the second 30 min after a standard 75 g oral glucose tolerance test (OGTT). Glucose and insulin levels were measured at baseline and 30, 60, 90, 120 and 180 min afterwards. Results: Glucose fluctuations during OGTT were not modified by 4 or 6 Oral-lyn puffs. Treatment with 12 puffs was followed by 29.6% decrease in plasma glucose at 2 h and 26.8% decrease at 3 h, altogether p = 0.01. Considering all time points of the OGTT, there was a mean reduction of 15.8% in glucose levels. With 6 of the total 12 puffs used in group C there was a significant increase in the insulin levels during OGTT at 30 min (p < 0.04) but not at 2 or 3 h. No hypoglycaemic episodes were observed at any time points of the OGTT. Conclusions: This proof-of-concept study demonstrates that treatment with buccal spray insulin is a simple and valuable therapy for reducing postprandial hyperglycaemia in obese subjects with IGT. Importantly, this treatment is safe and none of the study subjects experienced hypoglycaemia.