Long-term safety and effectiveness of biosimilar insulin glargine in Japanese patients with diabetes mellitus in routine clinical practice: results of a post-marketing safety study

Abstract

Objective

To evaluate the long-term safety and effectiveness of biosimilar insulin glargine (GLY) in real-world clinical practice.

Methods

This prospective, non-interventional, multicenter, observational, post-marketing safety study (PMSS) enrolled Japanese patients with type 1 or 2 diabetes mellitus (T1DM or T2DM) starting GLY therapy, and was required by Japanese Pharmaceutical Affairs Law mandating post-marketing safety surveillance to acquire safety and effectiveness data of biosimilar products. Data collected from the 12-month observation included patient characteristics, adverse events, and blood glucose control.

Results

The study enrolled 141 patients with T1DM and 1104 patients with T2DM. Pre-study insulin was used by 94.1% of patients with T1DM and 75.0% with T2DM. 65.4% of patients with T1DM and 64.3% with T2DM switched from the reference product (GLY-switched), while 25.0% with T2DM were insulin-naive. Adverse events were reported by 5.7% and 8.5% in T1DM and T2DM, respectively. Similar incidences were reported in GLY-switched. Adverse events were reported by 10.7% in insulin-naive T2DM. Baseline mean hypoglycemic events/month were 1.8 and 0.1 in T1DM and T2DM, respectively: the mean change from baseline (CFB) was –1.2 (p = .066) and 0.0 (p = .915), respectively. Baseline mean HbA1c was 8.4% and 8.7% in T1DM and T2DM, respectively; the mean CFB was –0.5% (p < .001) and –0.9% (p < .001), respectively, and –1.5% (p < .001) in insulin-naive T2DM.

Conclusions

This first long-term Japanese PMSS of GLY demonstrated adverse events, hypoglycemia, and glycemic control consistent with the known GLY profile for T1DM and T2DM patients, in routine clinical practice.

Keywords:

• Insulin glargine
• biosimilar
• type 1 diabetes mellitus
• type 2 diabetes mellitus
• post-marketing safety study

Transparency

Declaration of funding

This study was sponsored and funded by Eli Lilly Japan K.K. and Nippon Boehringer Ingelheim.

Declaration of financial/other relationships

All authors are full-time employees at Eli Lilly Japan K. K. and shareholders at Eli Lilly and Company. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

TS contributed to the conception and design of the study. MK contributed to acquisition of the study data. TS and SN contributed to analysis of the study data. All authors contributed to interpretation of the data, drafting or critical revision of the article, approved the final version to be published, and agree to be accountable for all aspects of the work.

Acknowledgements

The authors thank the study patients and their families, and the site investigators and clinical staff. The authors thank Jennifer Bodie, PhD, Gina M. Coudriet, PhD, Andrew Sakko, PhD, CMPP, Antonia Baldo, and Noelle Gasco (Syneos Health Clinical, Morrisville, NC, USA) for compensated contract assistance with manuscript preparation.

Notes

i LANTUS is a registered trade name of Sanofi K.K., Tokyo, Japan.