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Table 2 Baseline Patient Demographics (Randomized Populations)

From: Similar immunogenicity profiles between the proposed biosimilar MYL-1501D and reference insulin glargine in patients with diabetes mellitus: the phase 3 INSTRIDE 1 and INSTRIDE 2 studies

  INSTRIDE 1 (T1DM) INSTRIDE 2 (T2DM)a
MYL‑1501D (n=280) Reference insulin glargine (n=278) MYL‑1501D (n=277) Reference insulin glargine (n=283)
Age, mean (SD), y 42.0 (12.0) 42.2 (12.0) 55.0 (7.9) 55.1 (7.5)
Sex, n (%)
 Male 164 (58.6) 172 (61.9) 147 (53.1) 165 (58.3)
 Female 116 (41.4) 106 (38.1) 130 (46.9) 118 (41.7)
Race, n (%)
 White 263 (93.9) 265 (95.3) 147 (53.1) 148 (52.3)
 Hispanic 6 (2.1) 3 (1.1) 73 (26.4) 76 (26.9)
 Black 2 (0.7) 5 (1.8) 37 (13.4) 18 (6.4)
 Asian 2 (0.7) 2 (0.7) 9 (3.2) 19 (6.7)
 Hawaiian native 0 (0.0) 0 (0.0) 0 (0.0) 4 (1.4)
 American Indian 0 (0.0) 0 (0.0) 0 (0.0) 1 (0.4)
 Other 7 (2.5) 3 (1.1) 11 (4.0) 17 (6.0)
Geographic region, n (%)
 North America 126 (45.0) 126 (45.3) 225 (81.2) 228 (80.6)
 Europe 145 (51.8) 145 (52.2) 34 (12.3) 33 (11.7)
 Middle East and Africa 9 (3.2) 7 (2.5) 14 (5.1) 18 (6.4)
 East Asia 0 (0.0) 0 (0.0) 4 (1.4) 4 (1.4)
BMI, mean (SD), kg/m2 26.4 (3.7) 26.6 (4.2) 31.6 (4.8) 31.5 (4.4)
Duration of diabetes, mean (SD), y 18.7 (11.8) 19.7 (11.3) 12.0 (7.1) 11.3 (6.0)
HbA1c, mean (SD), mmol/mol 57.1 (9.5) 57.2 (9.2) 65.5 (12.5) 65.3 (12.4)
HbA1c, mean (SD), % 7.4 (0.9) 7.4 (0.8) 8.1 (1.1) 8.1 (1.1)
FPG, mean (SD), mmol/L 9.3 (3.8) 9.1 (3.4) 8.6 (3.0) 8.6 (3.1)
Mealtime insulin dose, mean (SD), U/kg 0.36 (0.17) 0.35 (0.15)
Daily basal insulin dose, mean (SD), U/kgb 0.31 (0.12) 0.32 (0.15) 0.22 (0.25) 0.24 (0.28)
Total daily insulin dose, mean (SD), U/kg 0.68 (0.23) 0.69 (0.24)
  1. BMI body mass index, FPG fasting plasma glucose, HbA1c glycated hemoglobin, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus
  2. aOne patient in each treatment group did not receive study drug during the treatment period
  3. bOnly non–insulin-naive patients were included in the insulin dose summary for INSTRIDE 2