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Objective.The objectives of the present study were to assess pharmacokinetics,preliminary pharmacodynamics,and safety of subcutaneous injection administration of lyophilized recombinant glucagon-like peptide-1 receptor agonist (rE-4) in Chinese patient with T2DM.Design and Methods.This is a 2-centre,randomized,opened,and controlled study.Patients were randomly assigned to three groups for 12 weeks respectively.One of trial groups was single drug treatment with rE-4,the other trial group was rE-4 plus metformin (Met),the controlled group was single drug treatment with Exenatide.All subjects received research drugs for 12 weeks.To compare the pharmacokinetic parameters of rE-4 with or without Met and Exenatide,the primary pharmacodynamic endpoint was the change of baseline to endpoint of HbA1c.Result.36 patients (age 38~68 years) were in rolled,29 subjects finished the study.Endpoints.The main pharmacokinetic parameters,Cmax and AUC,among three treatments,displayed no significant statistical difference (P>0.05).With or without MET,main pharmacokinetic parameters of rE-4 showed the same characters,but AUC was little higher in rE-4 plus MET treatment.The changes of HbA1c from baseline to endpoint receiving rE-4 and rE-4 plus MET (-1.19 ± 0.69 n=8,-0.84 ± 1.11 n=8) were similar with Exenatide (-1.13 ± 0.87 n=9),and three treatments showed no significant diffidence.Conc1usion: rE-4 with or without Met treatment improved glycemic control in Chinese patients with T2DM.