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Table 4. Seven-point blood glucose for patients who received basal-bolus treatment only with no OAD use.

Among the 22 patients who switched to Lantus due to suboptimal glycemic control as recorded in their medical records, FBG decreased from 10.17 (3.59) mmol/L to 8.51 (2.18) mmol/L (p=0.0540) during treatment with Basalin, and between insulin switch and hospital discharge decreased further to 7.37 (1.70) mmol/L (p=0.0337) ( nicekicks for sale Manolo Blahnik Okkato slippers shop offer free shipping for sale q8xpQv
). Among these patients, an overall trend towards reduction in seven-point blood glucose was also observed. Similar to the results in the main analysis population, the mean final doses of Basalin and Lantus were comparable (0.25 [0.08] IU/kg/day vs. 0.26[0.1] IU/kg/day; p=0.5069), as were the mean final doses of prandial insulin at final administrations of Basalin and Lantus (0.43 (0.13) IU/kg/day vs. 0.41 [0.14] IU/kg/day; p=0.5085) ( Supplementary Table 3 ).

Hypoglycemia was reported by 2 (2.4%) of patients during treatment with Basalin insulin glargine, and by 1 (1.2%) of patients during treatment with Lantus. No patients experienced severe hypoglycemia during hospitalization.

Dataset 1. Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine, propensity score matching with readme file explain the analysis.

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Discussion

Our retrospective study found that Chinese patients with T2DM who initiated Basalin with pre-prandial insulin or OADs achieved further reductions in overall hyperglycemia, especially fasting hyperglycemia, after switching to Lantus (8.03 mmol/L vs. 7.30 mmol/L; p=0.0116) with a similar mean basal insulin dose (0.23 IU/kg/day vs. 0.24 IU/kg/day; p=0.8720). This result is consistent with a previous case series that found three Chinese patients with T2DM inadequately controlled with Basalin achieved improvements in glycemic control after switching to Lantus, with a similar dosage of insulin. Patients in our study were relatively young (59.8 years) with a moderate disease course (9.1 years), poor glycemic control (HbA1c of 8.9%) and a high proportion of existing diabetic complications (86.3%) but a comparatively low prevalence of cardiovascular disease (38.4%). This may explain why the clinical decision was made to switch to Lantus, after achieving sub-optimal glycemic control with Basalin.

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. Although patients in this previous study had a similar mean age, BMI and duration of T2DM as our study, there were several important differences. Firstly, patients in this previous study had a relatively high mean blood glucose level during the study period in both the Basalin group and Lantus group (9.35 mmol/L vs. 9.67 mmol/L, respectively; p=0.387), especially a high FBG concentration of nearly 10 mmol/L. Secondly, no insulin titration scheme was used and it was not a treat-to-target study, in contrast to our study which utilized insulin dose titration. Finally, the duration of the previous study was 5 days with crossover on day 3, and 2 days of insulin administration before and after cross over, which may not have allowed adequate time for a full washout of the initial insulin type.

Patients in this study had poor glycemic control at Baseline (HbA1c=8.9%) and required intensified therapy to rapidly lower blood glucose levels, despite the majority having already received treatment for T2DM. Previous studies in hospitalized Chinese patients with poorly-controlled T2DM receiving intensive insulin therapy have shown that glycemic control targets based on blood glucose levels (FBG and post-prandial glucose [PPG]) can be reached in around 4 days. In comparison, the mean duration of Basalin (10.8 days) and Lantus (6.6 days) insulin glargine in the present study was sufficient to allow glycemic control targets to be reached. Additionally, it should be noted that given the short-term nature of the intensified insulin treatment being assessed in this study, the use of FBG as the primary assessment of glycemic control is justified versus other longer-term biomarkers such as HbA1c, and a precedent has been set for this in previous studies of short-term intensive insulin treatment.

Evidence suggests that intensive insulin treatment can protect and improve β-cell function through achievement of optimal glycemic control. Furthermore, initiation of a basal-bolus insulin regimen is recommended by most treatment guidelines for treatment intensification in patients with T2DM who cannot achieve glycemic control with OADs and basal insulin and is also recommended for hospitalized patients. The majority of patients in this study initiated treatment with a basal-bolus insulin regimen and achieved reductions in mean seven-point blood glucose during Basalin treatment, and further reductions following the switch to Lantus with a similar final dose of prandial insulin to that recorded at the end of Basalin treatment (0.40 IU/kg/day at both time points). This suggests that the further reductions in FBG achieved with Lantus treatment contributed to the overall control of hyperglycemia. As the glycemic profile of diabetes patients consists of basal glycemia, basal hyperglycemia and postprandial hyperglycemia, reductions of “basal” hyperglycemia which is often expressed as “fasting” blood glucose levels have been hypothesized to contribute to a reduction of post-prandial hyperglycemic excursions. In addition, despite the use of an intensive basal-bolus regimen in the majority of patients, the incidence of confirmed hypoglycemia was similarly low during treatment with Basalin and Lantus (2.4% vs. 1.2%).

To determine the potential confounding effects of concomitant OAD and prandial insulin use on glycemic control associated with basal insulin , we conducted two subgroup analyses in patients treated with a purely basal-bolus regimen with no OAD use and patients with recorded switching from Basalin to Lantus due to suboptimal glycemic control, and in both of these subgroups mean FBG was lower after switching from Basalin; 8.25 mmol/L vs. 7.49 mmol/L (p=0.0217) and 8.51 mmol/Lvs.7.37 mmol/L (p=0.0337). Furthermore, the results of the Joint Asia Diabetes Evaluation (JADE) study also reported that biosimilar insulin use in Asia is associated with suboptimal glycemic control, indicated by higher FBG and HbA1c levels and a lower proportion of patients achieving glycemic control targets (HbA1c <7.0%) compared with originator insulin (13.6% vs. 17.2%).

There are several limitations of this analysis which deserve discussion. Firstly, this was a retrospective study that had many potential confounding factors including patient age, duration of DM, diabetic complications and co-morbidities, which may have affected treatment outcomes, insulin dose and safety. However, patients acted as their own controls, which reduces the effect of these confounding factors somewhat, particularly because most of the confounding factors would be constant over the relatively short mean durations of treatment and hospital stay. Secondly, all patients in this study were hospitalized with strictly-controlled diet, exercise and monitoring of blood glucose, which would be expected to have a positive effect on glycemic control independently of basal insulin treatment, and it may also be hypothesized that switching to a different basal insulin perceived as ‘superior’ could lead to a placebo effect. Although these are potential confounding factors for attributing improvements in glycemic control to basal insulin treatment alone, it should be noted that patients achieved sub-optimal glycemic control with Basalin during the initial part of their hospital stay (an average of 10 days) during which modified diet and lifestyle would be expected to have the largest positive impact on blood glucose levels. Finally, although this was a single-center study with limited data the patient profile is similar to that reported in the Fine Asia and ORBIT studies, which indicated our findings potentially have treatment implications generalizable to the broader population of Chinese patients with T2DM.

In conclusion, this study provides evidence from real-world clinical practice that switching from Basalin to Lantus is associated with an improvement in blood glucose levels, with a similar insulin dose, in hospitalized patients with T2DM. Despite the limitations of the present analysis, these findings warrant further investigation by crossover randomized controlled study or further real-world evidence from a larger population.

Data availability

Dataset 1: Switching from biosimilar (Basalin) to originator (Lantus) insulin glargine, propensity score matching with readme file explain the analysis 10.5256/f1000research.13923.d199674

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

Supplementary material

Click here to access the data .

Summary of insulin doses during initial treatment with Basalin insulin glargine and after switching to Lantus for patients who received basal-bolus therapy only without OADs

Seven-point blood glucose summary for patients who switched due to suboptimal glycemic control as recorded in medical records

Summary of insulin doses during initial treatment with Basalin insulin glargine and after switching to Lantus for patients who switched to Lantus due to suboptimal glycemic control as recorded in medical records

Seven-point blood glucose measurement for Chinese patients with diabetes mellitus at hospital admission, Basalin insulin glargine initiation, insulin switch, and hospital discharge

Seven-point blood glucose measurement for Chinese patients with diabetes mellitus who received basal-bolus treatment only with no OAD use (n=62) at hospital admission, Basalin insulin glargine initiation, insulin switch, and hospital discharge

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
version 1
Published: 18 四月 2018, 7:477
doi: 10.12688/f1000research.13923.1
© 2018 Hu X . This is an open access article distributed under the terms of the Creative Commons Attribution Licence , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Data associated with the article are available under the terms of the Creative Commons Zero "No rights reserved" data waiver (CC0 1.0 Public domain dedication).
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Hu X, Zhang L, Dong Y 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] 2018, :477 (doi: 10.12688/f1000research.13923.1 )
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Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations Key revisions are required to address specific details and make the paper fully scientifically sound
Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions
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Referee Report 11 五月 2018
Xia Li , Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, Changsha, China
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DOI: 10.5256/f1000research.15136.r33299
I recommend the indexing of this paper in your journal based on the following considerations: 1. This is one of the few papers discussing the effectiveness and safety between biosimilar insulin and originator insulin in real world clinical practice in a Chinese diabetes population. It releases the message that biosimilar is potentially different in effectiveness from originator as reported by previous papers. It helps provide a clinical implication to physicians and raise the necessity of long term observation or well designed trials to identify the differences in real world at the same time. 2. Despite the limitation of small sample size, short term treatment duration and potential bias mentioned in this paper, the authors smartly designed two subgroup analysis. It also showed that the mean FBG was lower after switching from Basalin to Lantus , 8.25mM vs. 7.49mM(p=0.0217,for purely basal-bolus regimen with no OAD population) and 8.51mM vs.7.37mM(p=0.0337,for recorded suboptimal glycemic control population). The conclusion is consistent as that in the whole group. 3. The graphs should be displayed in a simple wayto be well understood.

Is the work clearly and accurately presented and does it cite the current literature?

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