99-LB: A Phase 2b Study of Oral Insulin (Capsulin) Administered to Patients with Type 2 Diabetes

Abstract

Data from 93 patients, divided into three equal groups, were used to compare the efficacy of three different doses of insulin - 75iu, 150iu and 300iu - administered twice daily in enteric-coated capsules containing Diabetology’s Axcess™ oral delivery formulation. The study was conducted in 16 centres in India, and comprised a population diagnosed with diabetes for less than two years, with an average BMI of 25.7 kg/m2 and a mean HbA1c of 8.14%. There were no concomitant medications employed other than metformin, whose dose was fixed throughout the study. The study met its primary endpoint of fall in HbA1c ≥0.5 with a high level of significance, and falls in fasting plasma glucose, postprandial glucose, triglycerides and LDL cholesterol were also noted. There was no weight gain in any of the groups over the three-month period. The group demonstrating the highest level of efficacy was the 150iu twice daily group, which was the original anticipated target dose, based on previous studies. The data support progression of Diabetology’s oral insulin programme towards conduct of large-scale phase 3 studies. Disclosure R. R. C. New: Employee; Self; Diabetology Ltd. M. Bogus: None. G. N. Travers: Stock/Shareholder; Self; Axcess Ltd, Diabetology Ltd, Proxima Concepts Ltd, Stock/Shareholder; Spouse/Partner; Axcess Limited, Proxima Concepts Ltd. G. S. Namjoshi: None.