Table 1.
Baseline demographics and clinical characteristics of study population
| Baseline demographics and clinical characteristics | Treatment arma | |
|---|---|---|
| LY IGlar (N = 249)b | IGlar (reference insulin product) (N = 244)b | |
| Age, mean (years) | 58 (9) | 57 (10) |
| < 65 years, N (%) | 198 (80) | 190 (78) |
| Male, N (%) | 131 (53) | 126 (52) |
| Race, N (%) | ||
| American Indian or Alaska Native | 1 (0) | 0 |
| Asian | 116 (47) | 118 (48) |
| Black or African American | 15 (6) | 15 (6) |
| Multiple | 2 (1) | 1 (0) |
| White | 115 (46) | 110 (45) |
| Body weight (kg) | 81 (17) | 78 (19) |
| BMI (kg/m2) | 29 (5) | 29 (5) |
| HbA1c (%) | 8.66 (1.09) | 8.56 (1.02) |
| Entry HbA1c, N (%) | ||
| < 8.5% | 115 (46) | 121 (50) |
| < 7.0% | 13 (5) | 10 (4) |
| FPGc (mmol/L) | 8.36 (2.39) | 8.36 (2.31) |
| Duration of diabetes (years) | 12 (6) | 12 (6) |
| Insulin naïve, N (%) | 113 (45.4) | 110 (45.1) |
| Basal insulin, N (%)d | ||
| IGlar | 88 (65) | 83 (62) |
| Insulin detemir | 29 (21) | 30 (22) |
| NPH insulin | 19 (14) | 21 (16) |
| Frequency of basal insulin injection, N (%)d | ||
| Daily (IGlar, NPH, or insulin detemir) | 127 (93) | 125 (93) |
| Twice daily (NPH or insulin detemir) | 9 (7) | 9 (7) |
| Time of basal insulin injection, N (%) | ||
| Daytime | 99 (40) | 96 (39) |
| Evening/bedtime | 150 (60) | 148 (61) |
| Sulfonylurea use, N (%) | 207 (83) | 207 (85) |
Data are shown as the mean with the standard deviation in parentheses (SD), unless otherwise indicated
BMI Body mass index, FPG fasting plasma glucose, HbA1c hemoglobin A1c, IGlar insulin glargine (Lantus), LY IGlar Lilly insulin glargine, NPH neutral protamine Hagedorn, SD standard deviation, SMGB self-monitored blood glucose
aP> 0 .05 for all treatment comparisons
bFull analysis set, N values reflect maximum sample size
cBy SMBG assessments (SMBG whole blood samplings were recorded as plasma-equivalent glucose values)
dCalculations are based on the number of patients on basal insulin at entry (LY IGlar, 136; IGlar, 134)