TABLE 2.
Summary of clinical assessments at week 24 (FAS)
| Measurementa | LY IGlar (n = 359) | IGlar (n = 177) |
|---|---|---|
| HbA1c, % | ||
| Week 24 | 7.13 (0.043) | 7.18 (0.062) |
| Change from baseline to week 24 | −1.27 (0.043) | −1.23 (0.062) |
| LS mean difference (95% CI) | −0.05 (−0.19, 0.10) | |
| HbA1c, mmol/mol | ||
| Week 24 | 54.5 (0.47) | 55.0 (0.67) |
| Change from baseline to week 24 | −13.9 (0.47) | −13.4(0.67) |
| LS mean difference (95% CI) | −0.5 (−2.11, 1.11) | |
| HbA1c target values, n (%) | ||
| <7.0% (<53 mmol/mol) | 146 (43.7) | 71 (44.9) |
| ≤6.5% (≤48 mmol/mol) | 78 (23.4) | 26 (16.5) |
| FBG change from baselineb | ||
| mmol/L | −2.70 (0.061) | −2.76 (0.088) |
| mg/dL | −48.7 (1.09) | −49.7 (1.59) |
| Insulin dose | ||
| U/day | 16.0 (0.43) | 15.7 (0.61) |
| U/kg/day | 0.23 (0.006) | 0.22 (0.008) |
| Weight change from baseline, kg | 1.1 (0.13) | 1.2 (0.19) |
| Hypoglycaemia, n (%) [no. of events] | ||
| Total (≤70 mg/dL) | 180 (50.1) [581] | 96 (54.2) [295] |
| Total (<54 mg/dL) | 22 (6.1) [29] | 10 (5.7) [14] |
| Nocturnal | 53 (14.8) [101] | 25 (14.1) [40] |
| Severe | 0 | 0 |
| Hypoglycaemia rate overall,c mean (SD) | ||
| Total (≤70 mg/dL) | 3.96 (10.76) | 3.87 (7.39) |
| Total (<54 mg/dL) | 0.20 (1.00) | 0.19 (0.85) |
| Nocturnal | 0.76 (3.74) | 0.53 (1.61) |
| Severe | 0 | 0 |
| Detectable insulin antibodies, n (%) | 69 (19.3) | 31 (17.5) |
| Cross‐reactive insulin antibodies, n (%) | 53 (14.8) | 24 (13.6) |
| TEAR, n (%) | 61 (17.1) | 29 (16.4) |
a
All measurements are least squares mean (standard error) unless specified.
b
By self‐measured blood glucose.
c
Events/patient/year, the overall rate at week 24 accounts for all events reported during the 24‐week treatment period.
Abbreviations: CI, confidence interval; FAS, full analysis set; FBG, fasting blood glucose; IGlar, insulin glargine; LY IGlar, LY2963016 insulin glargine; LS, least squares; TEAR, treatment‐emergent antibody response.
p > .05 for all treatment group comparisons.