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Table 1 Characteristics of included studies

From: Efficacy and immunogenicity of insulin biosimilar compared to their reference products: a systematic review and meta-analysis

Study, Year Trial name Sample size (BSM/REF) BSM vs REF Race Study/Trial design Type of DM Time point, wk Duration of DM (y) HbA1C, % FPG, mmol/L BMI, Kg/m2 ADA (+), %
Long-acting insulin biosimilar
 Verma, 2011 [17] NA 107/108 Basalog vs Lantus Indian RCT/Non-inferiority 1 12 11 7.9 8.1 21.8 NA
 Kaku, 2016 [18] NA 131/129 FFP-112 vs Lantus Japanese RCT/Non-inferiority 1 24/52 NA 7.8 7.8 NA NA
 Blevins, 2015 [19] ELEMENT 1 268/267 LY Iglar vs Lantus White (74%), Asian (18%), American-Indian RCT/Non-inferiority 1 24/52 17 7.8 8.3 25.5 0.7
 Rosenstock, 2015 [20] ELEMENT 2 376/380 LY Iglar vs Lantus White (80%), Asian, Black RCT/Non-inferiority 2 24 12 8.3 8.8 32 NA
 Blevins, 2018 [21] INSTRIDE 1 280/278 MYL-1501D vs Lantus Europe
USA
RCT/Non-inferiority 1 24/52 19 7.4 9.2 26.5 NA
 Home, 2018 [22]  NA 245/263 MK-1293 vs Lantus White (80%), Asian, Black RCT/Non-inferiority 1 24/52 22 8 9.3 26.4 58
 Hollander, 2018 [23] NCT02059187 266/265 MK-1293 vs Lantus White (63%), Black (12.5%), Multi-racial (15%), Asian RCT/Non-inferiority 2 24 13 8.4 8.5 32.3 32
 Blevins, 2019 [24] INSTRIDE 2 277/283 MYL-1501D vs Lantus North America, East Asia, Eastern Europe, and other regions RCT/Non-inferiority 2 24 12 8.1 8.6 31.6 NA
 Karonova, 2020 [25] NCT04022993 90/90 GP40061 vs Lantus caucasian RCT/Non-inferiority 1 26 14 8.6 11 24.3 NA
Short-acting insulin biosimilar
 Garg, 2017 [26] SORELLA 1, 2017 253/254 SAR232434 vs Humalog NA RCT/Non-inferiority 1 26/52 19 8 10 NA 48
 Derwahl, 2018 [27] SORELLA 2, 2017 253/254 SAR232434 vs Humalog US, EU, RoW RCT/Non-inferiority 2 26 17 8 NA 32.2 25
 Garg, 2020 [28] GEMELLI 1 301/296 SAR341402 vs NovoRapid US, EU, RoW RCT/Non-inferiority 1.2 26 19 8 NA 27.5 36
 Karonova, 2021 [29] NCT04079413 132/132 GP-Asp vs NovoRapid European RCT/Non-inferiority 1 26 13.5 8.6 11 24.8 8.3
Pre-mixed insulin biosimilar
 Mayorov, 2020 [30] NCT04023344 105/105 GP-Lis25 vs Humalog Mix 25 Russia RCT/Non-inferiority 2 26 10 9.4 11.8 31 NA
  1. ADA (+)Anti-Drug-Antibody positive, BMI body mass index, BSM biosimilar, BW body weight, DM diabetes mellitus, FPG fasting plasma glucose, IGlar Lantus insulin glargine, LY IGlar LY2963016 insulin glargine, Ly-Lis Insulin lispro-Humalog, MYL lGar MYL-1501D (Mylan’s insulin glargine), MK IGlar MK-1293 insulin glargine, NA not available, REF reference, SAR-Lis SAR342434 insulin lispro, SD standard deviation