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

• Published in: Current medical research and opinion Vol. 36; no. 6; pp. 947 - 958
• Main Authors: Shingaki, Tomotaka, Taki, Kentaro, Koyanagi, Momoha, Nagaoka, Soshi, Yoshizawa, Kenichi, Oki, Norika, Yoshikawa, Aki, Imaoka, Takeshi
• Format: Journal Article
• Language: English
• Published: England Taylor & Francis 02.06.2020
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; biosimilar; Biosimilar Pharmaceuticals - therapeutic use; Blood Glucose - analysis; Child; Diabetes Mellitus - blood; Diabetes Mellitus - drug therapy; Female; Humans; Hypoglycemic Agents - therapeutic use; Insulin glargine; Insulin Glargine - adverse effects; Insulin Glargine - therapeutic use; Male; Middle Aged; post-marketing safety study; Product Surveillance, Postmarketing; Prospective Studies; type 1 diabetes mellitus; type 2 diabetes mellitus; Young Adult; type 2 diabetes mellitus; type 1 diabetes mellitus; Insulin glargine; post-marketing safety study; biosimilar
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1080/03007995.2020.1754182

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