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Item #5 

ADA: Oralin as a Meal Insulin in Treatment of Type-2 Diabetes

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

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