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.

CTR20232521 / Not yet recruitingPhase 2

在口服降糖药控制不佳（A部分）或既往使用基础/预混胰岛素控制不佳（B部分）的2型糖尿病患者中比较GZR101注射液与德谷门冬双胰岛素注射液（诺和佳®）的疗效、耐受性和安全性的多中心II期临床研究

[Translation] A multicenter phase II clinical study to compare the efficacy, tolerability and safety of GZR101 injection and degludec insulin aspart injection (Truojia®) in patients with type 2 diabetes who are poorly controlled by oral hypoglycemic drugs (Part A) or have been poorly controlled with basal/premixed insulin (Part B).

主要目的 A部分：对比GZR101注射液和德谷门冬双胰岛素注射液（诺和佳®）每日注射给药一次治疗16周后的疗效、安全性和耐受性。B部分：对比每日一次GZR101注射液联合每日一次门冬胰岛素和每日两次德谷门冬双胰岛素注射液（诺和佳®）治疗16周后的疗效、安全性和耐受性。次要目的研究GZR101注射液每日注射给药一次，治疗16周的GZR33（GZR101成分之一，在研超长效基础胰岛素类似物）和门冬胰岛素（GZR101成分之一，已上市速效胰岛素）的药代动力学（PK）特征。

[Translation]

Main objective Part A: To compare the efficacy, safety and tolerability of GZR101 injection and insulin degludec aspart injection (Novogam®) after 16 weeks of treatment with once-daily injection. Part B: To compare the efficacy, safety and tolerability of GZR101 injection once daily combined with insulin degludec aspart injection once daily and insulin degludec aspart injection twice daily (Novogam®) after 16 weeks of treatment. Secondary objective To study the pharmacokinetic (PK) characteristics of GZR33 (one of the components of GZR101, an ultra-long-acting basal insulin analog under development) and insulin degludec aspart (one of the components of GZR101, a rapid-acting insulin already on the market) after 16 weeks of treatment with GZR101 injection once daily.

Start Date-

Sponsor / Collaborator

Gan & Lee Pharmaceuticals Co., Ltd.

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.

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

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

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