Table 2.
Baseline Patient Demographics (Randomized Populations)
| 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) | — | — |
BMI body mass index, FPG fasting plasma glucose, HbA1c glycated hemoglobin, T1DM type 1 diabetes mellitus, T2DM type 2 diabetes mellitus
aOne patient in each treatment group did not receive study drug during the treatment period
bOnly non–insulin-naive patients were included in the insulin dose summary for INSTRIDE 2