[Translation] A multicenter, randomized, parallel, positive-controlled, phase III clinical study to evaluate the efficacy and safety of degludec insulin injection and Tresiba® in the treatment of patients with type 2 diabetes

观察2型糖尿病患者皮下注射试验药物德谷胰岛素注射液（江苏万邦生化医药集团有限责任公司生产）和对照药品德谷胰岛素注射液（诺和达®，诺和诺德（中国）制药有限公司生产），以评价德谷胰岛素注射液（试验药物）在2型糖尿病患者中的有效性和安全性。

[Translation]

To observe the subcutaneous injection of the investigational drug degludec injection (produced by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd.) and the control drug degludec injection (Truevoda®, produced by Novo Nordisk (China) Pharmaceutical Co., Ltd.) in patients with type 2 diabetes, so as to evaluate the efficacy and safety of degludec injection (investigational drug) in patients with type 2 diabetes.

Start Date27 Feb 2024

Sponsor / Collaborator

Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.

CTR20233587

/ CompletedPhase 1

评价德谷胰岛素注射液与诺和达®在中国健康男性受试者中随机、开放、单剂量、两制剂、两序列、两周期、双交叉的药代动力学和药效动力学I期临床试验

[Translation] A randomized, open-label, single-dose, two-formulation, two-sequence, two-period, double-crossover Phase I clinical trial to evaluate the pharmacokinetic and pharmacodynamic effects of degludec insulin injection and Tresiba® in healthy Chinese male subjects

主要目的：采用正葡萄糖钳夹技术，在中国健康男性受试者中比较江苏万邦生化医药集团有限责任公司生产的德谷胰岛素注射液（候选药，T）与诺和诺德（中国）制药有限公司生产的德谷胰岛素注射液（诺和达®，参照药，R）的药代动力学（PK）和药效动力（PD）的生物等效性。次要目的：评价德谷胰岛素注射液在中国健康男性受试者中的安全性和免疫原性。

[Translation]

Primary objective: To compare the pharmacokinetics (PK) and pharmacodynamics (PD) bioequivalence of degludec insulin injection (candidate drug, T) produced by Jiangsu Wanbang Biochemical Pharmaceutical Group Co., Ltd. and degludec insulin injection (Truevo®, reference drug, R) produced by Novo Nordisk (China) Pharmaceuticals Co., Ltd. in healthy Chinese male subjects using the euglycemic clamp technique. Secondary objective: To evaluate the safety and immunogenicity of degludec insulin injection in healthy Chinese male subjects.

Start Date24 Nov 2023

Sponsor / Collaborator

Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Insulin Degludec biosimilar(Jiangsu Wanbang)

100 Translational Medicine associated with Insulin Degludec biosimilar(Jiangsu Wanbang)

100 Patents (Medical) associated with Insulin Degludec biosimilar(Jiangsu Wanbang)

100 Deals associated with Insulin Degludec biosimilar(Jiangsu Wanbang)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	China	Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.	27 Feb 2024

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