Table 2.
Efficacy of insulin glargine 300 U/mL (Gla-300) in clinical studies
| EDITION 432 | EDITION JP133 | EDITION 134 | EDITION 236 | EDITION 331 | EDITION JP235 | |
|---|---|---|---|---|---|---|
|
| ||||||
| (T1DM) | (T1DM, Japan) | (T2DM) | (T2DM) | (T2DM) | (T2DM, Japan) | |
| Patient population | Adult T1DM, HbA1c 7%−10% | Adult Japanese T1DM, HbA1c 7%−10% | Adult T2DM, HbA1c 7%−10% | Adult T2DM, HbA1c 7%−10% | Adult T2DM, HbA1c 7%−11% | Adult Japanese T2DM, HbA1c 7%−10% |
| Study treatment Gla-300 or Gla-100, plus | Mealtime insulin analog | Mealtime insulin analog | Mealtime insulin analog ± metformin | OADs (SU discontinued) | OADs (SU discontinued) | OADs (SU continued with dose adjustments) |
| Previous treatment | Basal + mealtime insulin | Basal + mealtime insulin | Basal + mealtime insulin ± metformin | Basal insulin ± OADs | Insulin-naïve + noninsulin therapy | Basal insulin ± OADs |
| Sample size | Gla-300, n=274 | Gla-300, n=121 | Gla-300, n=404 | Gla-300, n=404 | Gla-300, n=435 | Gla-300, n=122 |
| Gla-100, n=275 | Gla-100, n=122 | Gla-100, n=403 | Gla-100, n=407 | Gla-100, n=438 | Gla-300, n=121 | |
| HbA1c (%) | ||||||
| Baseline mean | 8.1 | 8.1 | 8.2 | 8.2 | 8.5 | 8 |
| Mean change from baseline,a Gla-300 vs Gla-100 | Gla-300, −0.4 Gla-100, −0.44 |
Gla-300, −0.3 Gla-100, −0.43 |
Gla-300, −0.83 Gla-100, −0.83 |
Gla-300, −0.57 Gla-100, −0.56 |
Gla-300, −1.42 Gla-100, −1.46 |
Gla-300, −0.45 Gla-100, −0.55 |
| LSMΔ (95% CI) | 0.04 (−0.1 to 0.19) | 0.13 (−0.03 to 0.29) | 0 (−0.11 to 0.11) | −0.01 (−0.14 to 0.12) | 0.04 (−0.09 to 0.17) | 0.1 (−0.08 to 0.27) |
| Laboratory-measured FPG (mmol/L) | ||||||
|
Mean change from baselinea (mmol/L) LSMΔ (95% CI) |
Gla-300, −0.95 (SE 0.263) Gla-100, −1.14 (SE 0.26) |
0.4 (−0.6 to 1.4) | Gla-300, −1.29 (SD 0.19) Gla-100, −1.38 (SD 0.19) |
Gla-300, −1.14 (SD 3.42) Gla-100, −1.06 (SD 3.02) 0.19 (−0.15 to 0.52) |
Gla-300, −3.41 (SE 0.1) Gla-100, −3.80 (SE 0.11) 0.39 (0.1−0.68) |
0 (−0.4 to 0.5) |
| Weight (kg) | ||||||
| Mean weight change from baselinea (kg) | NR | Gla-300, 0.1 (SE 0.2) Gla-100, 0.4 (SE 0.2) P=0.0347 |
Gla-300, 0.9 Gla-100, 0.9 |
Gla-300, 0.08 (SD 3.45) Gla-100, 0.66 (SD 3.01) P=0.015 |
Gla-300, 0.49 (95% CI 0.14−0.83) Gla-100, 0.71 (95% CI 0.36−1.06)NS |
Gla-300, −0.62 (SE 0.19) Gla-100, 0.37 (SE 0.19) P=0.0003 |
| Insulin dose | ||||||
| Basal insulin dose at month 6 (U/kg/day unless otherwise indicated) | Gla-300, 0.47 (SD 0.22) Gla-100, 0.40 (SD 0.18) |
Gla-300, 0.35; 23 U/day Gla-100, 0.29; 18.2 U/day |
Gla-300, 0.97 (SD 0.37); 103 U/day Gla-100, 0.88 (SD 0.32); 94 U/day LSMΔ 0.09 (95% CI 0.062−0.124) |
Gla-300, 0.92 (SD 0.31); 91 U/day Gla-100, 0.84 (SD 0.28); 82 U/day LSMΔ 11 U/day (95% CI 8−14) |
Gla-300, 0.62 (SD 0.29); 59.4 U/day Gla-100, 0.53 (SD 0.24); 52 U/day |
Gla-300, 0.35 (SD 0.17); 24 U/day Gla-100, 0.3 (SD 0.14); 20 U/day |
| Mealtime insulin dose at month 6 (U/kg/day) | Gla-300, 0.34 Gla-100, 0.33 |
Gla-300, 0.44; 28 U/day Gla-100, 0.45; 27.8 U/day |
Gla-300, 0.55 (SD 0.35) Gla-100, 0.55 (SD 0.35) |
NA | NA | NA |
Notes:
a
LSMΔ at month 6 or last observation on treatment (last observation carried forward).
Abbreviations: T1DM, type 1 diabetes mellitus; HbA1c, glycated hemoglobin; LSMΔ, least-squares mean difference; CI, confidence interval; SD, standard deviation; SE, standard error; FPG, fasting plasma glucose; OADs, oral antidiabetic drugs; NR, not reported; NA, not applicable; Gla-300, insulin glargine 300 U/mL; Gla-100, insulin glargine 100 U/mL; T2DM, type 2 diabetes mellitus; SU, sulfonylurea.