Table 5.
Change in weight for Glar-300 versus Glar-100 across the EDITION phase 3 clinical trial program.
| Study | Change in body weight | P value |
|---|---|---|
| EDITION 1 | There was an increase in body weight in both treatment groups from a baseline (mean ± SD) of 106.11 ± 21.43 kg to 107.04 ± 21.86 kg with Glar-300 and 106.5 ± 19.94 kg to 107.4 ± 20.33 kg with Glar-100. The change was +0.93 kg with Glar-300 and +0.90 kg with Glar-100. | P = NS |
| EDITION 1, 12 mo treatment period | The mean (SD) change was +1.2 kg (3.8) with Glar-300 and +1.4 kg (3.5) with Glar-100 [LS mean difference: −0.2 kg (95% CI: −0.7 to 0.3)]. | P = NS |
| EDITION 2 | The mean (SD) change was +0.08 kg (3.45) with Glar-300 and +0.66 kg (3.01) with Glar-100. | P = 0.015 |
| EDITION 2, 12 mo treatment period | The mean (SD) change was +0.4 kg (4.1) with Glar-300 and +1.2 kg (3.6) with Glar-100 [LS mean difference: −0.7 kg (95% CI: −1.3 to− 0.2)]. | P = 0.009 |
| EDITION 3 | The LS mean change was +0.49 kg (95% CI: 0.14 to 0.83) with Glar-300 and +0.71 kg (95% CI: 0.36 to 1.06) with Glar-100. | P = NS |
| EDITION 3, 12 mo treatment period | The mean (SD) change was +0.97 kg (4.32) with Glar-300 and 1.2 kg (4.16) with Glar-100 [LS mean difference: −0.24 kg (95% CI: −0.81 to 0.33)]. | P = NS |
| EDITION 4 | The LS mean change (SE) was +0.5 kg (3.3) with Glar-300 and +1.0 kg (3.2) with Glar-100 [LS mean difference: −0.6 kg (95% CI: −1.1 to −0.03)]. | P = 0.037 |
| EDITION 4, 12 mo treatment period | The LS mean difference in change from BL to month 12 was −0.5 kg (−1.1 to 0.1). | P = 0.098 |
| EDITION JP1 | The LS mean change (SE) was −0.1 kg (0.2) with Glar-300 and +0.4 kg (0.2) with Glar-100 [LS mean difference: −0.6 kg (95% CI: −1.1 to −0.0)]. | P = 0.035 |
| EDITION JP1, 12 mo treatment period | The mean change (SE) was +0.06 kg (0.21) with Glar-300 and +0.41 (0.19) with Glar-100. | P = NS |
| EDITION JP2 | The LS mean change (SE) was −0.6 kg (0.2) with Glar-300 and +0.4 kg (0.2) with Glar-100 [LS mean difference: −1.0 kg (−1.5 to −0.5)]. | P = 0.0003 |
| EDITION JP2, 12 mo treatment period | The mean change (SD) was −0.7 kg (0.2) with Glar-300 and +0.5 kg (0.2) with Glar-100. | P = 0.0001 |
Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; LS: least squares; NS: not significant; SD: standard deviation; SE: standard error.