在口服降糖药疗效不佳的2型糖尿病受试者中评估联合重组人胰岛素肠溶胶囊治疗的有效性和安全性的随机、双盲、安慰剂对照研究
[Translation] A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of combined recombinant human insulin enteric-coated capsules in subjects with type 2 diabetes mellitus refractory to oral hypoglycemic agents
主要目的:在口服降糖药血糖控制不佳的2型糖尿病受试者中,评估联合重组人胰岛素肠溶胶囊(ORMD-0801明胶软胶囊,以下简称 ORMD-0801)治疗的有效性。
次要目的:在口服降糖药疗效不佳的2型糖尿病受试者中,评估联合ORMD-0801治疗的安全性及免疫原性。
[Translation] Main purpose: To evaluate the efficacy of combined recombinant human insulin enteric-coated capsules (ORMD-0801 gelatin soft capsules, hereinafter referred to as ORMD-0801) in subjects with type 2 diabetes mellitus with poor blood sugar control with oral hypoglycemic agents.
Secondary Objectives: To evaluate the safety and immunogenicity of combined ORMD-0801 therapy in subjects with type 2 diabetes who are not responding to oral hypoglycemic agents.
一项在健康受试者中评估ORMD-0801明胶软胶囊单次给药的安全性、耐受性、药代动力学及药效学特征的I期临床研究
[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose ORMD-0801 gelatin softgels in healthy subjects
主要目的: 评价ORMD-0801明胶软胶囊在健康志愿者中单次给药后的安全性和耐受性。 次要目的: 评价健康志愿者单次口服ORMD-0801明胶软胶囊后对血糖的药效动力学作用及对体内C肽、GLP-1的影响; 评价受试者单次口服ORMD-0801明胶软胶囊的药代动力学特征。
[Translation] Main objective: To evaluate the safety and tolerability of ORMD-0801 soft gelatin capsules in healthy volunteers after a single dose. Secondary objectives: To evaluate the pharmacodynamic effects on blood glucose and the effects on C-peptide and GLP-1 in vivo after a single oral administration of ORMD-0801 gelatin soft capsules in healthy volunteers; Pharmacokinetic characteristics of capsules.
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