Table 1.
Demographic and Baseline Characteristics—Randomized Population
| SAR-Lis (N = 253) | Ly-Lis (N = 252) | All (N = 505) | |
|---|---|---|---|
| Age (years), mean (SD) [n] | 62.1 (9.4) [253] | 62.8 (8.9) [252] | 62.5 (9.1) [505] |
| Age groups, n (%) | |||
| <65 | 144 (56.9) | 137 (54.4) | 281 (55.6) |
| ≥65 to <75 | 89 (35.2) | 93 (36.9) | 182 (36.0) |
| ≥75 | 20 (7.9) | 22 (8.7) | 42 (8.3) |
| Male gender, n (%) | 136 (53.8) | 132 (52.4) | 268 (53.1) |
| Race, n (%) | |||
| Caucasian/White | 228 (90.1) | 218 (86.5) | 446 (88.3) |
| Black | 14 (5.5) | 17 (6.7) | 31 (6.1) |
| Asian/Oriental | 11 (4.3) | 16 (6.3) | 27 (5.3) |
| Other | 0 | 1 (0.4) | 1 (0.2) |
| Ethnicity, n (%) | |||
| Hispanic | 43 (17.0) | 47 (18.7) | 90 (17.8) |
| Not Hispanic | 210 (83.0) | 205 (81.3) | 415 (82.2) |
| Regions, n (%) | |||
| United States | 122 (48.2) | 120 (47.6) | 242 (47.9) |
| Western Europe | 32 (12.6) | 37 (14.7) | 69 (13.7) |
| Eastern Europe | 67 (26.5) | 58 (23.0) | 125 (24.8) |
| Rest of the world | 32 (12.6) | 37 (14.7) | 69 (13.7) |
| Region-approved Humalog®, n (%) | |||
| US-approved Humalog | 122 (48.2) | 120 (47.6) | 242 (47.9) |
| EU-approved Humalog | 131 (51.8) | 132 (52.4) | 263 (52.1) |
| Baseline weight (kg), mean (SD) [n] | 92.2 (17.5) [253] | 91.2 (17.4) [252] | 91.7 (17.4) [505] |
| Baseline BMI (kg/m2), mean (SD) [n] | 32.3 (4.8) [253] | 32.1 (4.8) [252] | 32.2 (4.8) [505] |
| Baseline BMI categories, n (%) | |||
| <25 | 17 (6.7) | 18 (7.1) | 35 (6.9) |
| ≥25 to <30 | 62 (24.5) | 72 (28.6) | 134 (26.5) |
| ≥30 | 174 (68.8) | 162 (64.3) | 336 (66.5) |
| Baseline estimated GFR (mL/min/1.73 m2), mean (SD) [n] | 77.29 (22.89) [253] | 78.48 (23.66) [252] | 77.89 (23.26) [505] |
| Baseline estimated GFR categories (mL/min/1.73 m2), n (%) | |||
| ≥90 | 69 (27.3) | 67 (26.6) | 136 (26.9) |
| ≥60 to <90 | 130 (51.4) | 135 (53.6) | 265 (52.5) |
| ≥30 to <60 | 51 (20.2) | 49 (19.4) | 100 (19.8) |
| <30 | 3 (1.2) | 1 (0.4) | 4 (0.8) |
| Randomization strata of screening HbA1c categories, n (%) | |||
| <8% | 105 (41.5) | 104 (41.3) | 209 (41.4) |
| ≥8% | 148 (58.5) | 148 (58.7) | 296 (58.6) |
| Randomization strata of prior use of Humalog, n (%) | |||
| Yes | 155 (61.3) | 155 (61.5) | 310 (61.4) |
| No | 98 (38.7) | 97 (38.5) | 195 (38.6) |
| Duration of T2DM (years), mean (SD) [n] | 16.60 (7.93) [253] | 17.52 (8.67) [252] | 17.06 (8.31) [505] |
| Duration of T2DM categories (years), n (%) | |||
| <10 | 50 (19.8) | 47 (18.7) | 97 (19.2) |
| ≥10 | 203 (80.2) | 205 (81.3) | 408 (80.8) |
| Age at onset of T2DM (years), mean (SD) [n] | 46.0 (10.1) [253] | 45.8 (10.2) [252] | 45.9 (10.1) [505] |
| Duration of basal bolus insulin treatment (years), mean (SD) [n] | 7.10 (5.67) [247] | 7.99 (6.76) [243] | 7.54 (6.24) [490] |
| Duration of mealtime insulin treatment in patient life (years), mean (SD) [n] | 6.43 (5.54) [250] | 7.17 (6.33) [247] | 6.80 (5.95) [497] |
| Previous basal insulin type, n (%) | |||
| Insulin glargine | 253 (100) | 251 (99.6) | 504 (99.8) |
| Duration of insulin glargine treatment (years), mean (SD) [n] | 5.75 (4.62) [253] | 5.97 (4.69) [252] | 5.86 (4.65) [505] |
| Previous mealtime insulin type, n (%) | |||
| Humalog/Liprolog® | 133 (52.6) | 126 (50.2) | 259 (51.4) |
| NovoLog®/NovoRapid® | 119 (47.0) | 124 (49.4) | 243 (48.2) |
| Both Humalog/Liprolog and NovoLog/NovoRapid | 1 (0.4) | 1 (0.4) | 2 (0.4) |
| Duration of previous treatment with Humalog/Liprolog (years), mean (SD) [n] | 5.36 (5.29) [134] | 4.64 (4.55) [127] | 5.01 (4.95) [261] |
| Duration of previous treatment with NovoLog/NovoRapid (years), mean (SD) [n] | 4.51 (4.41) [120] | 5.72 (5.40) [125] | 5.13 (4.97) [245] |
| Baseline HbA1c,%, mean (SD) [n] | 7.99 (0.87) [253] | 8.03 (0.91) [252] | 8.01 (0.89) [505] |
BMI, body mass index; GFR, glomerular filtration rate; Ly-Lis, Humalog insulin lispro; SAR-Lis, SAR342434 insulin lispro; SD, standard deviation; T2DM, type 2 diabetes mellitus.