Table 1.
Characteristics of At-Goal (12 or 24 Weeks) Population (Who Provided a Baseline Glycated Hemoglobin A1c) in the DURABLE Trial
| Variable | Treatment group | p value | |
| LM75/25 (n = 584) | Insulin glargine (n = 508) | ||
| Baseline A1C (%), mean (SD) | 8.7 (1.2) | 8.6 (1.1) | 0.05 |
| Baseline A1C (%) group (n, %) | |||
| >9.6% | 122 (20.9%) | 88 (17.3%) | |
| 8.81–9.6% | 100 (17.1%) | 89 (17.5%) | |
| 8.21–8.8% | 118 (20.2%) | 94 (18.5%) | |
| 7.71–8.2% | 107 (18.3%) | 104 (20.5%) | |
| ≤7.7% | 137 (23.5%) | 133 (26.2%) | |
| Initial total daily insulin dose (U/kg/day),a mean (SD) | 0.36 (0.13) | 0.27 (0.13) | <0.0001 |
| Age (years), mean (SD) | 58.0 (9.5) | 57.7 (9.3) | 0.54 |
| Duration of diabetes (years), mean (SD) | 9.6 (6.3) | 9.5 (6.0) | 0.79 |
| Gender (% female) | 49.0% | 44.7% | 0.16 |
| BMI (kg/m2), mean (SD) | 31.7 (5.9) | 31.8 (5.9) | 0.96 |
| Fasting insulin (μIU/ml), mean (SD) Median (25th percentile, 75th% percentile) |
9.8 (7.8)7.9 (4.9, 12.2) | 9.5 (8.1) 7.1 (4.8, 11.1) |
0.56 |
| Race/ethnicity (n, %) | |||
| African American | 29 (5.0%) | 28 (5.5%) | 0.71a |
| Asian | 48 (8.2%) | 48 (9.5%) | |
| Caucasian | 419 (71.8%) | 359 (70.7%) | |
| East Asian | 6 (1.0%) | 10 (2.0%) | |
| Hispanic | 68 (11.6%) | 51 (10.0%) | |
| Other | 14 (2.4%) | 12 (2.4%) | |
| A1C reduction (%), SIT stratified mean (standard error) | -2.18% (0.02) | -2.11% (0.02) | 0.03c |
| Total daily insulin dose (U/kg) at point of control, mean (SD) Hypoglycemia (episodes/year) at point of control mean (SD) |
0.42 (0.18) 44.5 (54.7) |
0.34 (0.18) 34.6 (42.8) |
<0.0001 <0.001 |
a
LM75/25 minimum starting dose was 10 U twice daily. Glargine minimum starting dose was 10 U once daily.
b
The p value is the result of the test whether the distribution of the variable race is different between the two treatments.
a
p values are significant at p < .05 level.