Table 2.
Key efficacy and safety outcomes
| Outcome | ELEMENT 5 total population | India subpopulation | East Asia subpopulation | |||
|---|---|---|---|---|---|---|
| LY IGlar N = 249 |
IGlar N = 244 |
LY IGlar N = 49 |
IGlar N = 51 |
LY IGLar N = 67 |
IGlar N = 67 |
|
| HbA1c, %, LSM (SE) | ||||||
| At week 24 | 7.36 (0.07) | 7.39 (0.07) | 7.77 (0.18) | 7.98 (0.17) | 7.35 (0.12) | 7.36 (0.12) |
| Change from baselinea | − 1.25 (0.07) | − 1.22 (0.07) | − 0.83 (0.18) | − 0.62 (0.17) | − 1.28 (0.12) | − 1.26 (0.12) |
| LS mean diff (95% CI) | − 0.04 (− 0.22, 0.15) | − 0.21 (− 0.70, 0.28) | − 0.02 (− 0.34, 0.30) | |||
| Target HbA1c (n [%]) | ||||||
| < 7.0% | 83 (36.7) | 88 (39.5) | 8 (20.5) | 5 (11.4) | 20 (30.3) | 28 (43.1) |
| ≤ 6.5% | 48 (21.2) | 44 (19.7) | 2 (5.10) | 3 (6.80) | 12 (18.20) | 11 (16.90) |
| Self-monitored FBGa, LSM (SE) | ||||||
| Change from baseline (mmol/L) | − 2.37 (0.08) | − 2.69 (0.08) | − 2.41 (0.10) | − 2.87 (0.10) | − 1.9 (0.16) | − 1.99 (0.16) |
| Change from baseline (mg/dL) | − 42.8 (1.49) | − 48.4 (1.49) | − 43.40 (1.86) | − 51.80 (1.75) | − 34.10 (2.79) | − 35.80 (2.79) |
| Basal insulin dosea, LSM (SE) | ||||||
| U/day | 49.8 (2.16) | 49.70 (2.17) | 30.8 (2.89) | 36.50 (2.76) | 31.40 (2.09) | 34.70 (2.09) |
| U/kg/day | 0.58 (0.02) | 0.61 (0.02) | 0.42 (0.04) | 0.53 (0.04) | 0.44 (0.03) | 0.50 (0.03) |
| Weight (change from baseline, kg, LSM [SE])a | + 2.3 (0.28) | + 1.7 (0.29) | + 1.7 (0.40) | + 1.6 (0.42) | + 0.7 (0.32) | + 1.2 (0.32) |
| Hypoglycemia rateb (overallc; events/patient/y; mean [SD]) | ||||||
| Total (≤ 3.9 mmol/L or 70 mg/dL) | 16.95 (23.44) | 23.37 (35.81) | 2.38 (5.01) | 8.81 (28.51) | 19.30 (23.09) | 21.08 (22.11) |
| Nocturnal (≤ 3.9 mmol/L or 70 mg/dL) | 6.64 (11.65) | 7.94 (17.88) | 0.78 (2.21) | 4.92 (25.86) | 6.50 (9.88) | 6.09 (10.71) |
| Patients with detectable antibodies (n [%]) | ||||||
| Baseline | 46 (19.7) | 27 (11.3) | 3 (7.3) | 3 (6.0) | 8 (12.3) | 7 (10.4) |
| Overallc | 68 (29.1) | 66 (27.6) | 7 (17.1) | 8 (16.0) | 20 (30.8) | 20 (29.9) |
| % Insulin antibody binding (median) | 1.90 | 0.80 | 3.15 | 4.34 | 1.96 | 0.99 |
Values presented are for Week 24, unless otherwise indicated
p > 0.05 for all comparisons between LY IGlar and IGlar in all three populations except FBG for ELEMENT 5 total population (p = 0.007) and India (p = 0.002)
CI confidence interval, diff difference, FBG fasting blood glucose, HbA1c glycated hemoglobin, IGlar insulin glargine (Lantus), LSM least-squares mean, LY IGlar Lilly insulin glargine, MMRM mixed model repeated measures, SD standard deviation, SE standard error
aAnalyzed using the MMRM method
bAnalyzed using the Negative Binomial method
cMeasured for the overall 24-week treatment period