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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

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Abstract

Aim

To 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).

Methods

One 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.

Results

No 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.

Conclusion

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.

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Acknowledgements

The study was supported by the fund of Scientific and Technological Development Program of Jiangsu Province of China (BL2014010).

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Author notes

  1. H. Q. Li and C. F. Lu equally contributed as first authors.

Authors and Affiliations

  1. Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, 210029, China

    H. Q. Li, C. F. Lu, J. Wang, G. P. Yin, R. Sun, X. H. Xu, B. L. Liu, F. F. Li, T. Jing, J. H. Ma & X. F. Su

  2. Division of Endocrinology, Department of Medicine, National University of Singapore, Singapore, Singapore

    K. O. Lee

  3. National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore, Singapore

    L. Ye

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  1. H. Q. Li
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  2. C. F. Lu
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  5. R. Sun
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Corresponding authors

Correspondence to J. H. Ma or X. F. Su.

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Conflict of interest

The authors declare that they have no conflicts of interest.

Ethical approval

This crossover study was approved by Ethical Committee of Nanjing First Hospital, Nanjing Medical University, Nanjing, China.

Informed consent

Informed consents were signed by all patients.

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Li, H.Q., Lu, C.F., Wang, J. et al. A comparison of clinical efficacy and economic value in Basalin- and Lantus-treated patients with type 2 diabetes using continuous glucose monitoring system. J Endocrinol Invest 41, 179–184 (2018). https://doi.org/10.1007/s40618-017-0712-0

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  • DOI: https://doi.org/10.1007/s40618-017-0712-0

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