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Research Article
Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine is effective in Chinese patients with diabetes mellitus: a retrospective chart review [version 1; referees: 3 approved, 1 approved with reservations]
Xia Hu, Lei Zhang, Yanhu Dong, Chao Dong, Jikang Jiang, cheap sale newest Oamc paint stripe detailed sneakers best store to get for sale xaOhsWdOb
Xia Hu, Lei Zhang, [...] Yanhu Dong, Chao Dong, Jikang Jiang, Weiguo Gao
PUBLISHED 18 四月 2018
Xia Hu Roles: Conceptualization, Data Curation, Investigation, Project Administration, Writing – Original Draft Preparation, Writing – Review Editing
Lei Zhang Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review Editing
Yanhu Dong Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review Editing
Chao Dong Roles: Conceptualization, Data Curation, Formal Analysis, Methodology, Writing – Original Draft Preparation, Writing – Review Editing
Jikang Jiang Roles: Conceptualization, Investigation, Methodology, Writing – Original Draft Preparation, Writing – Review Editing
Weiguo Gao Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Project Administration, Supervision, Writing – Original Draft Preparation, Writing – Review Editing
REFEREE STATUS

Abstract

This study investigated the effectiveness and safety of switching from Basalin® to Lantus® in Chinese patients with diabetes mellitus (DM). 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. 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. 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.

Keywords

Insulin glargine, biosimilar, diabetes mellitus, Lantus, Basalin

Corresponding Author(s)
Weiguo Gao ( weiguo.gao@diabeteschina.com )
Grant information: The author(s) declared that no grants were involved in supporting this work.

Introduction

In China, insulin is more widely used to treat patients with type 2 diabetes mellitus (T2DM) compared with many Western countries. Chinese patients with T2DM are characterized by a relatively young age of diabetes onset, low bodyweight, and early β-cell dysfunction combined with insulin resistance. Furthermore, progressive deterioration of β-cell function is known to contribute to the increasing difficulty of achieving glycemic control experienced during the T2DM disease course. Therefore, interventions to preserve β-cells are recognized to be effective and, considering the early β-cell dysfunction which characterizes Chinese T2DM patients, can be especially effective in this population. However, challenges for implementing insulin treatment in China include lack of patient education, limitations of medical resources, inadequate health care systems making patient follow up difficult, and suboptimal blood glucose monitoring. Therefore, Chinese physicians often prefer to initiate intensified treatment regimens in an inpatient setting to allow close control of treatment, and monitoring of effectiveness and safety. Given this situation, early initiation of insulin treatment in an inpatient setting is often favored in China for the treatment of patients with T2DM. Several studies in Chinese patients with newly-diagnosed T2DM have shown that early intensive insulin treatment preserves β-cell function and leads to glycemic remission. Furthermore, a meta-analysis of previous studies showed that 46.3% of Chinese patients with T2DM who received intensive insulin treatment achieved glycemic remission after 12 months, without the use of anti-diabetic medication and relying solely on lifestyle modification to control blood glucose levels.

Basal insulin is recommended as a convenient way to initiate insulin treatment by most international treatment guidelines, and by the Chinese Diabetes Association. ( see the International Diabetes Federations Diabetes Atlas, 7 edition ) As reported by the large, observational ORBIT study, insulin glargine is the most popular basal insulin for the initiation of insulin treatment in Chinese patients with T2DM (71%), followed by detemir (13%) and neutral protamine Hagedorn (NPH)(16%) insulin. In China, there are two available versions of insulin glargine; the originator Lantus® (Sanofi), and the biosimilar Basalin® ( see Gan Lee Pharmaceuticals history page ), which has been commercially available since 2005 in China, Egypt, Pakistan, South East Asia, and countries in Latin America. Basalin was the first biosimilar of insulin glargine marketed in China, and has since become a commonly used treatment option for many Chinese physicians. 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. 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. However, other than these two previous reports, there are no further confirmatory studies in real-world clinical practice. In addition, a local-language case report described improved blood glucose control and reduced insulin dose in three Chinese patients with T2DM who switched from Basalin to Lantus due to suboptimal glycemic control. Given this situation, it is important to further verify the findings of this case report in a larger population of patients who switched from Basalin to Lantus in a real-life clinical practice setting. We therefore hypothesized that patients with diabetes who switch from Basalin to Lantus in a real-world setting may achieve improved control of blood glucose with a similar safety profile.

This was a retrospective chart review conducted based on the electronic medical records (EMRs) of patients hospitalized at the Qingdao Endocrine and Diabetes Hospital from 2005 to 2016. Qingdao Endocrine and Diabetes Hospital is a public, non-profit, tertiary hospital that was established in 2002 and is located in Qingdao city, one of the biggest cities on the east coast of China. The Hospital is the only specialist diabetes hospital, not only in Qingdao, but also throughout the region, with a catchment area of approximately 100 kilometers, which covers 7.2 million people. The majority of the patients treated in the Hospital are Han Chinese residing in Qingdao city and the surrounding regions. Less than 1% of patients are national ethnic minorities or of foreign origin. In general, patients are hospitalized due to suspected acute diabetic complications including ketosis, ketoacidosis, diabetic hyperosmolality, uncontrolled hyperglycemia and at least one chronic complication, or significant worsening of chronic complications of diabetes (including rental hemorrhage, significant elevated albuminuria and/or serum creatinine, acute myocardial infarction, etc.).

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IMPORTANT: HTTPS endpoints are only available if you used Recommended Setup , followed Getting Started guide to deploy Dashboard or manually provided --tls-key-file and --tls-cert-file flags. In case you did not and you access Dashboard over HTTP, then Dashboard can be accessed the same way as Maison Margiela chunky heel mules best store to get online sale online 91xA6
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IMPORTANT:

NOTE : Dashboard should not be exposed publicly over HTTP. For domains accessed over HTTP it will not be possible to sign in. Nothing will happen after clicking Sign in button on login page.

kubectl proxy creates proxy server between your machine and Kubernetes API server. By default it is only accessible locally (from the machine that started it).

First let's check if kubectl is properly configured and has access to the cluster. In case of error follow this guide to install and set up kubectl .

Start local proxy server.

Once proxy server is started you should be able to access Dashboard from your browser.

To access HTTPS endpoint of dashboard go to: http://localhost:8001/api/v1/namespaces/kube-system/services/https:kubernetes-dashboard:/proxy/

NOTE: Dashboard should not be exposed publicly using kubectl proxy command as it only allows HTTP connection. For domains other than localhost and 127.0.0.1 it will not be possible to sign in. Nothing will happen after clicking Sign in button on login page.

This way of accessing Dashboard is only recommended for development environments in a single node setup.

Edit kubernetes-dashboard service.

You should see yaml representation of the service. Change type: ClusterIP to type: NodePort and save file. If it's already changed go to next step.

Next we need to check port on which Dashboard was exposed.

Dashboard has been exposed on port 31707 (HTTPS) . Now you can access it from your browser at: https://<master-ip>:31707 . master-ip can be found by executing kubectl cluster-info . Usually it is either 127.0.0.1 or IP of your machine, assuming that your cluster is running directly on the machine, on which these commands are executed.

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