[Translation] A multicenter, randomized, open-label, parallel-controlled phase III clinical study comparing the efficacy and safety of semaglutide injection and Novotel® in the treatment of type 2 diabetes subjects with poor glycemic control on metformin

主要研究目的：评估司美格鲁肽注射液和诺和泰®在单用二甲双胍治疗后血糖控制不佳的 2 型糖尿病患者中的疗效相似性。次要研究目的：评估司美格鲁肽注射液和诺和泰®在单用二甲双胍治疗后血糖控制不佳的 2 型糖尿病患者中的安全性;评估司美格鲁肽注射液和诺和泰®在单用二甲双胍治疗后血糖控制不佳的 2 型糖尿病患者中的免疫原性;观察司美格鲁肽注射液在 2 型糖尿病患者中多次给药后的药代动力学特征。

[Translation]

The main purpose of the study is to evaluate the similarity of the efficacy of semaglutide injection and Novota® in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone. Secondary study objectives: To evaluate the safety of semaglutide injection and Novota® in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone; to evaluate the immunogenicity of semaglutide injection and Novota® in patients with type 2 diabetes who have poor glycemic control after treatment with metformin alone; to observe the pharmacokinetic characteristics of semaglutide injection in patients with type 2 diabetes after multiple administrations.

Start Date11 Apr 2024

Sponsor / Collaborator

Chengdu Brilliant Pharmaceutical Company

NCT06339086

/ Not yet recruitingPhase 3

A Multicenter, Randomized, Open-label and Parallel-controlled Phase III Study to Compare the Efficacy and Safety of Semaglutide Injection With Ozempic® in the Treatment of Type 2 Diabetes Subjects With Poor Glycemic Control on Metformin

The goal of this clinical trial is to evaluate the similarities in efficacy and safety of semaglutide injection and Ozempic® in patients with type 2 diabetes who have poor glycemic control after metformin treatment.
Participants will receive either a dose of semaglutide or Ozempic® once weekly (subcutaneous injection) as add-on to metformin for 32 weeks.
Researchers will compare the outcomes of semaglutide and Ozempic® group to see if the efficacy, safety, pharmacokinetics, and immunogenicity of them are similar.

Start Date01 Apr 2024

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

CTR20240492

/ CompletedPhase 1

一项司美格鲁肽注射液与诺和泰®在健康受试者中的单中心、随机、开放、单次给药、平行对照的药代动力学比对试验

[Translation] A single-center, randomized, open-label, single-dose, parallel-controlled pharmacokinetic comparison study of semaglutide injection and Novotel® in healthy subjects

主要研究目的：比较受试制剂司美格鲁肽注射液与参比制剂诺和泰®空腹状态下单次皮下注射给药后在中国健康受试者中的药代动力学，评价两种制剂的药代动力学相似性。次要研究目的：评价司美格鲁肽注射液在健康受试者中单次给药的安全性。

[Translation]

Primary study objective: To compare the pharmacokinetics of the test preparation semaglutide injection and the reference preparation Novotel® in healthy Chinese subjects after a single subcutaneous injection under fasting conditions, and to evaluate the pharmacokinetic similarity of the two preparations. Secondary study objective: To evaluate the safety of a single dose of semaglutide injection in healthy subjects.

Start Date17 Feb 2024

Sponsor / Collaborator

Chengdu Brilliant Pharmaceutical Company

100 Clinical Results associated with Semaglutide biosimilar (Brilliant)

100 Translational Medicine associated with Semaglutide biosimilar (Brilliant)

100 Patents (Medical) associated with Semaglutide biosimilar (Brilliant)

100 Deals associated with Semaglutide biosimilar (Brilliant)

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 3	CN	Chengdu Brilliant Pharmaceutical Company	30 Sep 2024
Diabetes Mellitus, Type 2	Phase 3	-	Brilliant Pharmaceutical Co. Ltd.	01 Apr 2024

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