Background:
Oshadi Drug Administration Ltd. has developed an oral carrier for Insulin aiming to cope with its gastrointestinal rapid enzymatic degradation.
Objectives:
To assess the pharmacodynamics, safety, and glucose-lowering effect of Oshadi-Icp in young patients with type 1 diabetes (T1D).
Research design and methods
Phase I was a single blinded crossover between Oshadi-I and placebo. Phase Ib was a crossover open label comparison between two sessions of multiple-dose administration of a fixed dose of Oshadi Icp or placebo, while receiving reduced doses of the subcutaneous (SC) insulin. Phase II was a prospective multiple-dose, open-label study which included 4 weeks of Oshadi Icp at home, with a reduced dose of SC insulin.
Results
A total of 34 patients, mean age 26.75(±4.77) years, were included in all studies. Oshadi-Icp was well tolerated with no adverse events. Phase I demonstrated significantly lower peak and glucose AUC with Oshadi-Icp compared with placebo (219.22mg/dl±25.98 vs. 252.83mg/dl±12.95, 1116.08±107.01 vs. 1345.71±82.05 P <0.01). Phase Ib demonstrated all day AUC of glucose was lower during the 3rd day of Oshadi-Icp, compared to placebo (3107.57mg/dl±20.5 vs. 4031.58mg/dl±26.76 respectively, p<0.001), with lower insulin TDD compared to placebo (0.14±0.04 IU/kg/day vs. 0.18±0.06 IU/kg/day respectively, p≤0.01). Phase II study demonstrated the ratio of SC insulin dose to carbohydrate intake was significantly lower.
Conclusions: Those studies showed the substantial safety and the glucose lowering effect of Oshadi-Icp formulation. Its clinical beneficial effect for T1D patients should be further studied.
