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

Li, H. Q.; Lu, Chunfeng; Wang, J.; Yin, Gang; Sun, Rui; Xu, Xianghong; Liu, B. L.; Li, F. F.; Jing, Ting; Lee, Kok-Onn; Ye, Lei; H., J.; Su, Xiaofei

doi:10.1007/s40618-017-0712-0

Cited by 6 publications

(10 citation statements)

References 19 publications

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“…In contrast to our findings, a recently published blinded crossover study showed non-inferiority in terms of mean blood glucose, glucose fluctuations and rates of hypoglycemia as measured by CGMS for Chinese outpatients with T2DM receiving Basalin or Lantus 16 . Although patients in this previous study had a similar mean age, BMI and duration of T2DM as our study, there were several important differences.…”

Section: Discussioncontrasting

confidence: 99%

“…However, while biosimilars are developed to be highly similar to originator therapies, due to the degree of natural variability inherent to biological drugs, which are produced using living organisms, and because of differences in manufacturing processes between products, they are not identical to the original therapy 15 . Results from a previous head-to-head study of Basalin and Lantus in Chinese people with T2DM showed equivalent glycemic control and safety, and a further crossover study in Chinese people with T2DM using a continuous glucose monitoring system (CGMS) reported non-inferiority of Basalin to Lantus for mean blood glucose, blood glucose fluctuations and rates of hypoglycemia 16 , 17 . However, other than these two previous reports, there are no further confirmatory studies in real-world clinical practice.…”

Section: Introductionmentioning

confidence: 99%

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Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review

Zhang

Dong

et al. 2018

F1000Res

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Background: This study investigated the effectiveness and safety of switching from Basalin® to Lantus® in Chinese patients with diabetes mellitus (DM). Methods: A retrospective chart review conducted using the electronic medical records of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. All patients were diagnosed with DM and underwent switching of insulin from Basalin to Lantus during hospitalization. Data collected included fasting (FBG), pre- and post-prandial whole blood glucose, insulin dose, reasons for insulin switching and hypoglycemia. Four study time points were defined as: hospital admission, Basalin initiation, insulin switching (date of final dose of Basalin), and hospital discharge. Blood glucose measurements were imputed as the values recorded closest to the dates of these four time points for each patient. Results: Data from 73 patients (70 patients with type 2 diabetes, 2 with type 1, and 1 undisclosed) were analyzed. At admission, mean glycated hemoglobin (HbA1c) and FBG were 8.9% (SD=1.75) and 9.98 (3.22) mmol/L, respectively. Between Basalin initiation and insulin switch, mean FBG decreased from 9.68 mmol/L to 8.03 mmol/L (p<0.0001), over a mean 10.8 (SD=6.85) days of Basalin treatment, and reduced further to 7.30 mmol/L at discharge (p=0.0116) following a mean 6.6 (7.36) days of Lantus. The final doses of Basalin and Lantus were similar (0.23 vs. 0.24 IU/kg/day; p=0.2409). Furthermore, reductions in pre- and post-prandial blood glucose were also observed between Basalin initiation, insulin switch and hospital discharge. The incidence of confirmed hypoglycemia was low during Basalin (2 [2.4%]) and Lantus (1 [1.2%]) treatment, with no cases of severe hypoglycemia. Conclusion: In this study population, switching from Basalin to Lantus was associated with further reductions in blood glucose, although the dose of insulin glargine did not increase. Further studies are required to verify these findings and determine the reason for this phenomenon.

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Section: Discussioncontrasting

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review

Zhang

Dong

et al. 2018

F1000Res

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“…8 Ezelin (EZL) is an insulin glargine produced by Gan & Lee Pharmaceutical Ltd. or known in its home country as Basalin. 9,10 In Indonesia, EZL has obtained marketing authorization as biosimilar insulin glargine. EZL has proven its efficacy and safety in the previous clinical trial compared to the originator insulin glargine, which is Lantus (LAN).…”

Section: Introductionmentioning

confidence: 99%

“…EZL has proven its efficacy and safety in the previous clinical trial compared to the originator insulin glargine, which is Lantus (LAN). 9 To be able to replace its originator insulin product, the requirements that must be fulfilled by biological products are their similar efficacy, safety, and potential for immunogenicity. 7,11,12 Biological products, especially biosimilar, have the potential to cause an immunogenic response and may affect the efficacy and safety profile of the drug.…”

Section: Introductionmentioning

confidence: 99%

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes

Tarigan¹,

Dwijayanti²,

Setyowati³

et al. 2021

DMSO

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“…Overall, CGM is primarily recommended to patients with type 1 diabetes and those with type 2 diabetes on intensive insulin therapy or who experience dramatic glycemic variability. When appropriate, CGM can also be used in clinical research as a valuable tool for assessing and guiding treatment Real‐time CGM is mainly applicable to the following patients or conditions: children and adolescents with type 1 diabetes whose HbA 1c less than 7%.…”

Section: Clinical Indications For Cgm Technologymentioning

confidence: 99%

Chinese clinical guidelines for continuous glucose monitoring (2018 edition)

Bao

Chen

et al. 2019

Diabetes Metabolism Res

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Summary Blood glucose monitoring is an important part of diabetes management. Continuous glucose monitoring (CGM) technology has become an effective complement to conventional blood glucose monitoring methods and has been widely applied in clinical practice. The indications for its use, the accuracy of the generated data, the interpretation of the CGM results, and the application of the results must be standardized. In December 2009, the Chinese Diabetes Society (CDS) drafted and published the first Chinese Clinical Guideline for Continuous Glucose Monitoring (2009 edition), providing a basis for the standardization of CGM in clinical application. Based on the updates of international guidelines and the increasing evidence of domestic studies, it is necessary to revise the latest CGM guidelines in China so that the recent clinical evidence can be effectively translated into clinical benefit for diabetic patients. To this end, the CDS revised the Chinese Clinical Guideline for Continuous Glucose Monitoring (2012 Edition) based on the most recent evidence from international and domestic studies.

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

Abstract: Glargine-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.

Cited by 6 publications

References 19 publications

Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review

Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review

Immunogenicity and Efficacy of Insulin Glargine Biosimilar Ezelin versus Originator Insulin Glargine in Patients with Type 2 Diabetes

Chinese clinical guidelines for continuous glucose monitoring (2018 edition)

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