[Translation] A multicenter, randomized, open, positive-controlled Phase III clinical trial comparing the efficacy and safety of United Lab's insulin degludec injection and Tresiba® in the treatment of type 2 diabetes

本研究使用珠海联邦制药股份有限公司研制生产的德谷胰岛素注射液和诺和达®对2 型糖尿病患者进行为期24 周的治疗，比较治疗前后糖化血红蛋白（HbA1c）、空腹血糖下降和达标率等；同时比较两组低血糖事件的发生率和其它相关安全性指标及免疫原性指标相似性。主要目的是评价联邦制药研制的德谷胰岛素注射液对2 型糖尿病患者的有效性及安全性。

[Translation]

This study used degludec insulin injection and Tresiba® developed and produced by Zhuhai United Pharmaceutical Co., Ltd. to treat patients with type 2 diabetes for 24 weeks, and compared the reduction and achievement rate of glycated hemoglobin (HbA1c) and fasting blood glucose before and after treatment; at the same time, the incidence of hypoglycemia and other related safety indicators and immunogenicity indicators were compared between the two groups. The main purpose is to evaluate the effectiveness and safety of degludec insulin injection developed by United Pharmaceutical in patients with type 2 diabetes.

Start Date28 Feb 2022

Sponsor / Collaborator

Zhuhai United Laboratories Holding Ltd.

CTR20212703 / CompletedPhase 1

随机、开放、两周期、自身交叉对照设计，采用葡萄糖钳夹技术评价空腹状态下德谷胰岛素注射液与“诺和达®”在中国健康成年男性受试者中药效学和安全性比对试验

[Translation] A randomized, open-label, two-period, self-crossover controlled trial using glucose clamp technology to evaluate the pharmacodynamics and safety of degludec injection and Tresiba® in healthy Chinese adult male subjects under fasting conditions

比较中国健康成年男性受试者单次皮下注射德谷胰岛素注射液（受试制剂）与原研产品诺和达®（参比制剂）的药效学相似性，评价德谷胰岛素注射液的安全性，初步评价德谷胰岛素的免疫原性。

[Translation]

To compare the pharmacodynamic similarity of a single subcutaneous injection of degludec insulin injection (test preparation) and the original product Tresiba® (reference preparation) in healthy adult male Chinese subjects, evaluate the safety of degludec insulin injection, and preliminarily evaluate the immunogenicity of degludec insulin.

Start Date29 Nov 2021

Sponsor / Collaborator

Zhuhai United Laboratories Holding Ltd.

CTR20202645 / CompletedPhase 1

随机、开放、两周期、自身交叉对照评估联邦制药德谷胰岛素注射液和诺和达在健康男性受试者中药动学、药效学和安全性比对临床试验

[Translation] A randomized, open-label, two-period, self-crossover clinical trial to evaluate the pharmacokinetics, pharmacodynamics and safety of insulin degludec injection from United Lab and Tresiba in healthy male subjects

考察德谷胰岛素注射液的药动学特征，并比较中国健康成年男性受试者单次皮下注射德谷胰岛素注射液（受试制剂）与原研产品诺和达®（参比制剂）的药动学相似性。评价德谷胰岛素的药效学特性、安全性。初步评价德谷胰岛素的免疫原性。

[Translation]

To investigate the pharmacokinetic characteristics of degludec insulin injection and compare the pharmacokinetic similarity of a single subcutaneous injection of degludec insulin injection (test preparation) with the original product Tresiba® (reference preparation) in healthy adult male subjects in China. To evaluate the pharmacodynamic properties and safety of degludec insulin. To preliminarily evaluate the immunogenicity of degludec insulin.

Start Date01 Mar 2021

Sponsor / Collaborator

Zhuhai United Laboratories Holding Ltd.

100 Clinical Results associated with Insulin Degludec biosimilar(Zhuhai United Laboratories)

100 Translational Medicine associated with Insulin Degludec biosimilar(Zhuhai United Laboratories)

100 Patents (Medical) associated with Insulin Degludec biosimilar(Zhuhai United Laboratories)

100 Deals associated with Insulin Degludec biosimilar(Zhuhai United Laboratories)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CN	Zhuhai United Laboratories Holding Ltd.	28 Feb 2022

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