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Issue 110 Item 5 ADA: Oralin as a Meal Insulin in Treatment of Type-2 Diabetes

Apr 23, 2002

RapidMist, a novel buccal diabetes rapid insulin delivery device. The painful nature of injections is a major problem for Type-2 diabetics failing on oral agents and most patients are reluctant to go on injections. The alternative to this is the RapidMist, a novel Diabetes Management System based on a unique liquid aerosol formulation of oral insulin (Oralin). It allows a precise insulin dose delivery as fine aerosolized droplets directed in the mouth and rapidly absorbed through the buccal and oropahrynx mucosae. In the present study we evaluated the efficacy of the Oralin versus s.c. injection (0.11u/kg) in controlling post-prandial glucose in 11 Type-2 diabetic patients after a standard meal challenge. In a single blind, randomized, crossover study, 11 Type-2 diabetic patients received Oralin (15 puffs) via the RapidMist device or s.c. injection (0.11u/kg) followed by a 360 cals Ensure meal, 10 mins after the dose. The table below shows serum glucose, insulin and C-peptide changes from the baseline.

Time, Injection Oral Injection Oral Injection Oral

min Glucose Glucose Insulin Insulin C-peptide C-peptide

mg/dl mg/dl uU/ml uU/ml ng/ml ng/ml

0 163 183 47 32 0.52 0.47

15 168 180 67 88 0.55 0.46

60 227 213 74 50 1.01 0.76

120 262 254 71 47 1.44 1.05

240 199 204 70 29 0.92 0.77

We conclude that the oral insulin absorption and elimination was much faster when compared to s.c injection (Tmax=88, at 15 min) and outperformed s.c. injection in terms of glucose and C-peptide lowering capacity as well as rise in the insulin levels. American Diabetes Association’s 62nd Annual Scientific Sessions