[Translation] A multicenter, randomized comparison of the efficacy and safety of an imported similar product (NovoRapid) and insulin aspart (Radoxil) combined with metformin in the treatment of diabetes mellitus

主要目的：根据HbA1c的情况，判断锐秀霖是否疗效非劣于诺和锐；次要目的：比较锐秀霖治疗组和诺和锐治疗组与基线相比达到目标HbAlc＜7.0%,和≤6.5%的受试者百分比、餐后2h血糖及空腹血糖的变化等

[Translation]

Primary purpose: To determine whether the efficacy of Resolv is non-inferior to that of NovoRapid based on the HbA1c situation; Secondary purpose: To compare the percentage of subjects reaching the target HbAlc <7.0% and ≤6.5% in the Resolvv and NovoRapid treatment groups compared with baseline, and the changes in 2h postprandial blood glucose and fasting blood glucose, etc.

Start Date-

Sponsor / Collaborator-

CTR20180892 / Not yet recruitingPhase 1

以进口同类产品（诺和锐50）为交叉对照，评价门冬胰岛素50（锐秀霖50）对健康受试者的生物等效和安全性

[Translation] Using an imported similar product (NovoRapid 50) as a cross-reference, the bioequivalence and safety of insulin aspart 50 (Rapid 50) in healthy subjects were evaluated

通过葡萄糖钳夹试验，比较锐秀霖50和诺和锐50在药代动力学和药效动力学的生物等效性

[Translation]

Comparison of the pharmacokinetics and pharmacodynamics of Resoluline 50 and NovoRapid 50 using a glucose clamp test

Start Date-

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

NCT04237129 / CompletedPhase 1

A Glucose Clamp Trial Investigating The Biosimilarity of Gan & Lee Insulin Aspart Injection (Insulin Aspart 100 U/ml) With US and EU Insulin Aspart Comparator Products (NovoLog®/NovoRapid®) in Healthy Male Subjects

Primary objective:
To demonstrate pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of Gan & Lee Insulin Aspart Injection with both EU-approved NovoRapid® and US-licensed NovoLog® (Reference Products) in healthy male subjects
Secondary objectives:
To compare the PK and PD parameters of the three insulin aspart preparations
To evaluate the single dose safety and local tolerability of the three insulin aspart preparations

Start Date27 Aug 2019

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Translational Medicine associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Patents (Medical) associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

100 Deals associated with Insulin aspart biosimilar(Gan & Lee Pharmaceuticals Co., Ltd.)

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	A10AD05 A10AB05	DB01306

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	KZ	Gan & Lee Pharmaceuticals Co., Ltd.	26 Aug 2022
Diabetes Mellitus, Type 1	CN	Gan & Lee Pharmaceuticals Co., Ltd.	05 Jun 2020
Diabetes Mellitus, Type 2	CN	Gan & Lee Pharmaceuticals Co., Ltd.	05 Jun 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	NDA/BLA	US	Gan & Lee Pharmaceuticals Co., Ltd.	14 Jun 2023
Diabetes Mellitus, Type 1	Phase 3	CN	-	31 Oct 2013
Diabetes Mellitus, Type 2	Phase 3	CN	-	31 Oct 2013

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