[Translation] A multicenter, randomized, open-label, positive drug parallel-controlled phase III clinical study comparing the efficacy and safety of degludec injection (RD15003) and degludec injection (Truota®) in patients with type 2 diabetes

1. 主要目的：验证由东莞市东阳光生物药研发有限公司提供的德谷胰岛素注射液（RD15003）在2型糖尿病患者中的疗效非劣于原研药诺和诺德公司研发的德谷胰岛素注射液（诺和达®）。 2. 次要目的：评价由东莞市东阳光生物药研发有限公司提供的德谷胰岛素注射液（RD15003）与原研药诺和诺德公司研发的德谷胰岛素注射液（诺和达®）在2型糖尿病患者中的安全性、免疫原性是否具有相似性。

[Translation]

1. Primary objective: To verify that the efficacy of degludec insulin injection (RD15003) provided by Dongguan Dongyang Sunshine Biological Pharmaceutical Research and Development Co., Ltd. in patients with type 2 diabetes is non-inferior to that of degludec insulin injection (Truota®) developed by the original drug Novo Nordisk. 2. Secondary objective: To evaluate whether the safety and immunogenicity of degludec insulin injection (RD15003) provided by Dongguan Dongyang Sunshine Biological Pharmaceutical Research and Development Co., Ltd. and degludec insulin injection (Truota®) developed by the original drug Novo Nordisk in patients with type 2 diabetes are similar.

Start Date08 Nov 2021

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

CTR20211914 / CompletedPhase 1

一项在健康受试者中比较德谷胰岛素注射液（RD15003）与德谷胰岛素注射液（诺和达®）药代动力学和药效动力学特征的临床研究

[Translation] A clinical study comparing the pharmacokinetic and pharmacodynamic characteristics of degludec injection (RD15003) and degludec injection (Truota®) in healthy subjects

主要目的：以诺和诺德公司在中国上市的德谷胰岛素注射液（诺和达®）为对照药品，评价单剂量皮下注射东莞市东阳光生物药研发有限公司提供的德谷胰岛素注射液（RD15003）在健康受试者中的药代动力学和药效动力学特征，进而评价试验药物与对照药品的生物等效性。次要目的：评价东莞市东阳光生物药研发有限公司提供的德谷胰岛素注射液（RD15003）在健康受试者中的安全性与耐受性；评估东莞市东阳光生物药研发有限公司提供的德谷胰岛素注射液（RD15003）和诺和诺德公司在中国上市的德谷胰岛素注射液（诺和达®）在健康受试者中免疫原性的相似性。

[Translation]

Primary objective: To evaluate the pharmacokinetic and pharmacodynamic characteristics of a single subcutaneous injection of insulin degludec (RD15003) provided by Dongguan East Sunshine Biological Pharmaceuticals R&D Co., Ltd. in healthy subjects, using Novo Nordisk's insulin degludec injection (Truevo®) marketed in China as the control drug, and then evaluate the bioequivalence of the test drug and the control drug. Secondary objective: To evaluate the safety and tolerability of insulin degludec injection (RD15003) provided by Dongguan East Sunshine Biological Pharmaceuticals R&D Co., Ltd. in healthy subjects; to evaluate the similarity of immunogenicity between insulin degludec injection (RD15003) provided by Dongguan East Sunshine Biological Pharmaceuticals R&D Co., Ltd. and Novo Nordisk's insulin degludec injection (Truevo®) marketed in China in healthy subjects.

Start Date08 Oct 2021

Sponsor / Collaborator

Dongguan HEC Biopharmaceutical R&D Co., Ltd.

NCT05576298 / CompletedPhase 1

Pharmacokinetics, Pharmacodynamic, Safety and Immunogenicity Characteristics of Insulin Degludec Injection (RD15003) and Insulin Degludec Injection ( Tresiba®）in Healthy Subjects: a Phase I Single-center, Randomized, Open-label, Single-dose, Cross-over Clinical Study

To evaluate the single-dose subcutaneous injection of insulin degludec injection (Tresiba®) listed by Novo Nordisk in China as a reference drug, the insulin degludec injection provided by Dongguan Dongyang Sunshine Biopharmaceutical R&D Co., Ltd. (RD15003) pharmacokinetics and pharmacodynamic characteristics in healthy subjects, and then to evaluate the bioequivalence of test drugs and control drugs.

Start Date08 Oct 2021

Sponsor / Collaborator

Sunshine Lake Pharma Co., Ltd.

100 Clinical Results associated with Insulin Degludec biosimilar(HEC Biopharmaceutical)

100 Translational Medicine associated with Insulin Degludec biosimilar(HEC Biopharmaceutical)

100 Patents (Medical) associated with Insulin Degludec biosimilar(HEC Biopharmaceutical)

100 Deals associated with Insulin Degludec biosimilar(HEC Biopharmaceutical)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CN	Dongguan HEC Biopharmaceutical R&D Co., Ltd.	08 Nov 2021

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