Table 2.
Efficacy of Gla-300 vs Gla-100 in patients with T1DM
| Study | N | Duration (months) |
Background regimen | Comparators | N | Mean change from baseline to end of study
|
||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HbA1c (%) | Mean difference (95% CI)a |
FPG (mg/dL) |
Mean difference (95% CI)a |
Body weight (kg)b |
Mean difference (95% CI)a |
Basal insulin dose at end of study (baseline) U/kg/d | Difference at end of study (U/kg/d) | % Patients with HbA1c <7% | ||||||
| EDITION 4 (Home et al39) |
549 | 6 | Basal + mealtime insulin | Gla-300 | 273 | −0.42 | 0.04 (−0.10 to 0.19) | −17.1 | NR | +0.5 | −0.6 (−1.1 to −0.03)c | 0.47 (0.38) | +0.09 | 16.8 |
| Gla-100 | 273 | −0.44 | −20.5 | +1.0 | 0.40 (0.37) | +0.03 | 15.0 | |||||||
| EDITION JP1 (Matsuhisa et al40) |
243 | 6 | Basal + mealtime insulin | Gla-300 | 122 | −0.30 | 0.13 (−0.03 to 0.29) | −13.4 | 7.3 (−10.4 to 25.1) | −0.1 | −0.6 (−1.1 to −0.0)c | 0.35 (0.28) | +0.07 | 15.6 |
| Gla-100 | 121 | −0.43 | −20.8 | +0.4 | 0.29 (0.30) | −0.01 | 20.0 | |||||||
| EDITION JP1 Ext (Matsuhisa et al44) |
228 | 12 | Basal + mealtime Insulin | Gla-300 | 114 | −0.20 | NR | −14.4 | NR | NR | NR | 0.36 (0.28) | +0.08 | NR |
| Gla-100 | 114 | −0.25 | −7.2 | NR | 0.28 (0.30) | −0.02 | NR | |||||||
Notes: Measures of blood glucose control and insulin dose analyses based on modified intention-to-treat population.
a
Least-square mean difference (except in JP 1 where this is reported as mean change [standard deviation]);
b
analyses based on safety population;
c
statistically significant vs Gla-100.
Abbreviations: T1DM, type 1 diabetes mellitus; CI, confidence interval; Ext, extension study; Gla-100, insulin glargine 100 U/mL; Gla-300, insulin glargine 300 U/mL; HbA1c, glycosylated hemoglobin; FPG, fasting plasma glucose; NR, not reported.