Bioequivalence study of recombinant insulin glargine injection in Chinese healthy male subjects with random, open, single dose, two preparations, two sequences, four cycles, and repeated crossover design

Start Date12 Oct 2020

Sponsor / Collaborator-

ChiCTR2000037451 / SuspendedNot ApplicableIIT

A randomized, open-ended, single-dose, two-preparation, three-sequence, three-period, and partially repeated clinical study to compare the bioequivalence of recombinant insulin glargine injection and Laitse in healthy Chinese male subjects

Start Date27 Aug 2020

Sponsor / Collaborator-

CTR20170887 / CompletedPhase 3

比较重组甘精胰岛素注射液与来得时治疗2型糖尿病的有效性和安全性的多中心、随机、开放、非劣效性临床研究

[Translation] A multicenter, randomized, open, non-inferiority clinical study comparing the efficacy and safety of recombinant insulin glargine injection and Lantus in the treatment of type 2 diabetes

主要目的：评价重组甘精胰岛素注射液与来得时®（甘精胰岛素注射液）治疗2型糖尿病的有效性。次要目的：比较重组甘精胰岛素注射液与来得时®（甘精胰岛素注射液）治疗2型糖尿病的安全性。

[Translation]

Primary objective: To evaluate the effectiveness of recombinant insulin glargine injection and Lantus® (insulin glargine injection) in the treatment of type 2 diabetes. Secondary objective: To compare the safety of recombinant insulin glargine injection and Lantus® (insulin glargine injection) in the treatment of type 2 diabetes.

Start Date15 Mar 2018

Sponsor / Collaborator

Chongqing Fujin Biological Medicine Co Ltd

100 Clinical Results associated with Recombinant insulin glargine(Chongqing Fujin Biological Medicine Co Ltd)

100 Translational Medicine associated with Recombinant insulin glargine(Chongqing Fujin Biological Medicine Co Ltd)

100 Patents (Medical) associated with Recombinant insulin glargine(Chongqing Fujin Biological Medicine Co Ltd)

Literatures (Medical) associated with Recombinant insulin glargine(Chongqing Fujin Biological Medicine Co Ltd)

01 Jul 2018·Pharmaceutical ResearchQ3 · MEDICINE

Identification of N-Terminally Truncated Derivatives of Insulin Analogs Formed in Pharmaceutical Formulations

Q3 · MEDICINE

Article

Author: Stadnik, Jacek ; Bierczyńska-Krzysik, Anna ; Stadnik, Dorota ; Zielińska, Joanna

PURPOSEIsolation and identification of unknown impurities of recombinant insulin lispro (produced at IBA) formed during accelerated stability testing of pharmaceutical solutions. For comparative purposes also commercially available formulations of recombinant human insulin (Humulin S®; Lilly), recombinant insulin lispro (Humalog®; Lilly), recombinant insulin aspart (NovoRapid® Penfill®; Novo Nordisk), recombinant insulin detemir (Levemir®; Novo Nordisk) and recombinant insulin glargine (Lantus®; Sanofi-Aventis) were analyzed.METHODSThe impurities of insulin analogs were isolated by RP-HPLC and identified with peptide mass fingerprinting using MALDI-TOF/TOF mass spectrometry.RESULTSThe identified derivatives were N-terminally truncated insulin analog impurities of decreased molecular mass of 119, 147 and 377 Da related to the original protein. The modifications resulting in a mass decrease were detected at the N-terminus of B chains of insulin lispro, insulin aspart, human insulin, insulin glargine, insulin detemir in all tested formulations. To our knowledge it is the first time that these impurities are reported.CONCLUSIONSThe following derivatives formed by truncation of the B chain in insulin analogs were identified in pharmaceutical formulations: desPhe^B1-N-formyl-Val^B2 derivative, desPhe^B1 derivative, pyroGlu^B4 derivative.

01 Feb 2018·Journal of Endocrinological InvestigationQ2 · MEDICINE

A comparison of clinical efficacy and economic value in Basalin- and Lantus-treated patients with type 2 diabetes using continuous glucose monitoring system

Q2 · MEDICINE

Article

Author: Wang, J ; Li, H Q ; Yin, G P ; Xu, X H ; Ye, L ; Su, X F ; Lee, K O ; Lu, C F ; Ma, J H ; Sun, R ; Jing, T ; Liu, B L ; Li, F F

AIMTo determine the clinical non-inferiority of recombinant glargine-Basalin vs glargine-Lantus, in treatment of type 2 diabetes mellitus (T2DM) using continuous glucose monitoring system (CGMS).METHODSOne hundred patients with T2DM were recruited. They were either regularly taking Basalin (Basalin group) or Lantus (Lantus group) (n = 50 each). CGMS was employed to real-time monitor blood glucose profile for 4 days (from day 1 to day 5). To exclude the effect of patient background, the study design was to have a blinded crossover from glargine-Basalin to glargine-Lantus on day 3, and vice versa. 24-hour mean blood glucose (24hMBG), 24-hour standard deviation of blood glucose (24hSDBG), 24-hour mean amplitude of glycemic excursion (24hMAGE), and number of glycemic excursion (NGE) every 24 h (24hNGE) were calculated for each glargine from 100 patients.RESULTSNo significant difference of 24hMBG, 24hSDBG, 24hMAGE, and 24hNGE (p > 0.05 for all) was found between Basalin and Lantus treatments. The glucose area under the curve and time when blood glucose was below 3.9 mmol/L, between 3.9 and 10.0 mmol/L, or above 10.0 mmol/L were similar between Basalin and Lantus treatment. The frequency of hypoglycemic episodes was also similar. However, the mean cost of Basalin was only 72% of Lantus's in one treatment course.CONCLUSIONGlargine-Basalin is non-inferior in clinical efficacy compared to glargine-Lantus. In view of the large difference in the cost of glargine-Basalin, it would be much more cost-effective for our patients.

28 Oct 2016·Journal of Microbiology and BiotechnologyQ4 · ENGINEERING & TECHNOLOGY

Recombinant Glargine Insulin Production Process Using Escherichia coli

Q4 · ENGINEERING & TECHNOLOGY

Article

Author: Min, Cheol-Ki ; Kim, Kwang-Jin ; Yun, Jung-Mi ; Lee, Su Ui ; Lee, Se-Hoon ; Kim, Chang-Kyu ; Son, Young-Jin ; Hwang, Hae-Gwang

Glargine insulin is a long-acting insulin analog that helps blood glucose maintenance in patients with diabetes. We constructed the pPT-GI vector to express prepeptide glargine insulin when transformed into Escherichia coli JM109. The transformed E. coli cells were cultured by fed-batch fermentation. The final dry cell mass was 18 g/l. The prepeptide glargine insulin was 38.52% of the total protein. It was expressed as an inclusion body and then refolded to recover the biological activity. To convert the prepeptide into glargine insulin, citraconylation and trypsin cleavage were performed. Using citraconylation, the yield of enzymatic conversion for glargine insulin increased by 3.2-fold compared with that without citraconylation. After the enzyme reaction, active glargine insulin was purified by two types of chromatography (ion-exchange chromatography and reverse-phase chromatography). We obtained recombinant human glargine insulin at 98.11% purity and verified that it is equal to the standard of human glargine insulin, based on High-performance liquid chromatography analysis and Matrix-assisted laser desorption/ionization Time-of-Flight Mass Spectrometry. We thus established a production process for high-purity recombinant human glargine insulin and a method to block Arg (B31)-insulin formation. This established process for recombinant human glargine insulin may be a model process for the production of other human insulin analogs.

100 Deals associated with Recombinant insulin glargine(Chongqing Fujin Biological Medicine Co Ltd)

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	CN	Chongqing Fujin Biological Medicine Co Ltd	15 Mar 2018

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