American C.S.M. Company

Main purpose: This study used the hyperinsulinemic-euglycemic clamp technique as the test method to conduct a pharmacodynamic study on human insulin enteric-coated capsules and compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R). Secondary purpose: The pharmacokinetic study of human insulin enteric-coated capsules was conducted to compare the relative bioavailability of human insulin enteric-coated capsules and human insulin injection (Tianmailin® R).

Primary objective: To evaluate the efficacy of combined treatment with recombinant human insulin enteric-coated capsules (ORMD-0801 gelatin soft capsules, hereinafter referred to as ORMD-0801) in subjects with type 2 diabetes who have poor blood sugar control with oral hypoglycemic drugs. Secondary objective: To evaluate the safety and immunogenicity of combined treatment with ORMD-0801 in subjects with type 2 diabetes who have poor efficacy with oral hypoglycemic drugs.

Primary objective: To evaluate the safety and tolerability of ORMD-0801 gelatin soft capsules after a single dose in healthy volunteers. Secondary objective: To evaluate the pharmacodynamic effects of ORMD-0801 gelatin soft capsules on blood glucose and the effects on C-peptide and GLP-1 in vivo after a single oral dose in healthy volunteers; To evaluate the pharmacokinetic characteristics of ORMD-0801 gelatin soft capsules after a single oral dose in subjects.