[Translation] A randomized, open-label, parallel, positive-controlled Phase III clinical study comparing the clinical efficacy and safety of LY05008 and DuyiDa® in Chinese adult patients with type 2 diabetes

比较LY05008与度易达®在中国成人2型糖尿病患者中多次经皮下注射给药后临床疗效的相似性。

[Translation]

To compare the similarity of clinical efficacy between LY05008 and DuDa® after multiple subcutaneous injections in Chinese adult patients with type 2 diabetes.

Start Date-

Sponsor / Collaborator

Shandong Boan Biotechnology Co., Ltd.

JPRN-UMIN000024164 / CompletedIIT

Effects of dulaglutide and trelagliptin on beta-cell function in patients with type 2 diabetes: a randomized controlled study - DUET-beta study

Start Date29 Nov 2016

Sponsor / Collaborator

Yokohama City University

JPRN-UMIN000023394 / CompletedIIT

Match-up of two once weekly GLP-1 receptor agonists (exenatide,dulaglutide) about efficacy and satisfaction - Match-up of two once weekly GLP-1 receptor agonists

Start Date01 Aug 2016

Sponsor / Collaborator

Tokyo Medical University

100 Clinical Results associated with Dulaglutide Biosimilar(Shandong Boan Biological)

100 Translational Medicine associated with Dulaglutide Biosimilar(Shandong Boan Biological)

100 Patents (Medical) associated with Dulaglutide Biosimilar(Shandong Boan Biological)

Literatures (Medical) associated with Dulaglutide Biosimilar(Shandong Boan Biological)

03 Aug 2023·Expert Opinion on Biological Therapy

Pharmacokinetic similarity study comparing the biosimilar candidate, LY05008, with its reference product dulaglutide in healthy Chinese male subjects

Article

Author: Sun, Cheng ; Zhou, Renpeng ; Dou, Changlin ; Hu, Wei ; Zhang, Xuan ; Wu, Juan ; Liu, Yueyue ; Zhang, Qian ; Wu, Jinying ; Zhang, Qin ; Qin, Huilin

BACKGROUNDDulaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has been approved for improving glycemic control and reducing the risk of cardiovascular (CV) adverse events. This study compared the pharmacokinetic (PK) profiles, safety, and immunogenicity of LY05008, a biosimilar candidate, to a licensed product dulaglutide in healthy Chinese male subjects.RESEARCH DESIGN AND METHODSIn this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY05008 or dulaglutide subcutaneously. Primary study endpoints were PK parameters such as the area under the concentration-time curve (AUC) from time zero to infinity (AUC_{0 - ∞}), AUC from time zero to the last quantifiable concentration (AUC_0-t), and maximum serum concentration (C_max). Safety and immunogenicity profiles were also included for data analysis.RESULTS82 subjects were randomized to receive LY05008 (n = 41) or dulaglutide (n = 41). The 90% confidence intervals (CIs) of the geometric mean ratios (GMRs) of AUC_{0 - ∞,} AUC_0-t and C_max of LY05008 to dulaglutide were all within the bioequivalence limits of 80%-125%. Other PK parameters, safety, and immunogenicity profiles were comparable across the two treatment groups.CONCLUSIONThis study demonstrated PK similarity of LY05008, a dulaglutide biosimilar, to dulaglutide in healthy Chinese male subjects, with comparable safety and immunogenicity data.TRIAL REGISTRATIONThe trial is registered at the Chinese Clinical Trial Registry (Identifier No. ChiCTR2200066519).

100 Deals associated with Dulaglutide Biosimilar(Shandong Boan Biological)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	NDA/BLA	CN	Shandong Boan Biotechnology Co., Ltd.	28 May 2024

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