Safety of Insulin Lispro and a Biosimilar Insulin Lispro When Administered Through an Insulin Pump

James Thrasher, Howard Surks, Irene Nowotny, Suzanne Pierre, Baerbel Rotthaeuser, Karin Wernicke-Panten, Satish Garg, James Thrasher, Howard Surks, Irene Nowotny, Suzanne Pierre, Baerbel Rotthaeuser, Karin Wernicke-Panten, Satish Garg

Abstract

Background: SAR342434 (U100; SAR-Lis; insulin lispro) is a biosimilar/follow-on to insulin lispro (U100; Ly-Lis). Similar pharmacokinetics/pharmacodynamics between the two products has been demonstrated in a hyperinsulinemic euglycemic clamp study. The current study evaluated the safety of SAR-Lis and Ly-Lis when administered by continuous subcutaneous insulin infusion (CSII; insulin pumps).

Methods: This was a randomized, open-label, 2 × 4-week, two-arm crossover study in 27 patients with type 1 diabetes mellitus (NCT02603510). The main outcome was the incidence of infusion set occlusions (ISOs), defined as failure to correct hyperglycemia (plasma glucose ≥≥ 300 mg/dl) by 50 mg/dl within 60 minutes by insulin bolus via the pump. Secondary outcomes included intervals between infusion set changes, treatment-emergent adverse events (TEAEs) including infusion site, hypersensitivity reactions and hypoglycemic events, and safety.

Results: The number of patients reporting at least one ISO was small: 6/25 patients on SAR-Lis reported 14 ISOs and 4/27 on Ly-Lis reported nine ISOs. The estimated difference in ISO risk for SAR-Lis versus Ly-Lis was 7.9% (95% CI, -1.90 to 17.73). Mean interval between infusion set changes for any reason was similar with SAR-Lis (3.09 days) and Ly-Lis (2.95 days). The event rate (events/patient-month) of any hypoglycemia was similar with SAR-Lis (7.15) and Ly-Lis (7.98), as was the percentage of patients who experienced any TEAE (12.0% and 14.8%).

Conclusion: Both SAR-Lis and Ly-Lis were well tolerated by patients using insulin pumps. The results do not suggest a clinically significant difference in the risk of ISO between SAR-Lis and Ly-Lis when used in CSII.

Keywords: SAR342434; biosimilar; continuous subcutaneous insulin infusion; infusion set occlusion; insulin lispro; type 1 diabetes mellitus.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JT reports advisory board consulting fees from Sanofi, Medtronic, Novo Nordisk, and Pfizer Pharmaceuticals; research grants from Lexicon Pharmaceuticals Inc, Bristol-Myers Squibb, Eli Lilly and Co, Medtronic, Novo Nordisk, Sanofi, and Boehringer Ingelheim; speaker honoraria from Medtronic, Sanofi, Novo Nordisk, Lilly, Amylin, Bristol-Myers Squibb, Boehringer Ingelheim, Vivus, AstraZeneca, Daiichi-Sankyo, Takeda, GlaxoSmithKline, and Janssen. HS, IN, SP, BR, and KWP are employees of and stockholders in Sanofi. SG reports advisory board consulting fees from Medtronic, Roche, Merck, Lexicon, Novo-Nordisk, Sanofi, and Eli Lilly; research grants from Eli Lilly, Novo Nordisk, Merck, Lexicon, Medtronic, Dario, NCI, T1D Exchange, NIDDK, JDRF, and Sanofi; and reports no stocks or equity holdings in any device or pharmaceutical company.

Figures

Figure 1.
Figure 1.
Study design. R, randomization if HbA1c

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Source: PubMed

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