Table 1 Characteristics of included studies
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 |