Table 2.
Main glycemic responses of the participants in the EDITION clinical trial program.
| Glycemic responses | EDITION 1 | EDITION 2 | EDITION 3 | EDITION 4 | EDITION JP1 | EDITION JP2 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | Glar-300 | Glar-100 | |
| Mean change in HbA1c (%) from BL at month 6 | −0.83 | −0.83 | −0.57 | −0.56 | −1.42 | −1.46 | −0.42 | −0.44 | −0.3 | −0.43 | −0.45 | −0.55 |
| Mean change (difference) in HbA1c (%) from BL at month 6 | −0.00 (95% CI: −0.11 to 0.11) | −0.01 (95% CI: −0.14 to 0.12) | 0.04 (95% CI: −0.09 to 0.17) | 0.04 (95% CI: −0.10 to 0.19) | 0.13 (95% CI: −0.03 to 0.29) | 0.10 (95% CI: −0.08 to 0.27) | ||||||
| % of patients achieved HbA1c target (<7.0%) at month 6 | 39.6 | 40.9 | 30.6 | 30.4 | 43.1 | 42.1 | 16.8 | 15 | 15.6 | 20 | 25 | 24 |
| Mean change in HbA1c (%) from BL at month 12 | −0.86 | −0.69 | −0.55 | −0.50 | −1.29 | −1.21 | −0.20 | −0.22 | −0.2 | −0.3 | −0.3 | −0.3 |
| Mean change (difference) in HbA1c (%) between BL and month 12 | −0.17 (95% CI: −0.30 to −0.05) | −0.06 (95% CI: −0.22 to 0.10) | −0.08 (95% CI: −0.23 to 0.07) | 0.02 (95% CI: −0.13 to 0.17) | 0.2 (P = NS) | 0.0 (95% CI: −0.2 to 0.2) | ||||||
| Change in laboratory-measured FPG (mmol/L) between BL and month 6 | −1.48 | −1.69 | −1.14 | −1.06 | −3.41 | −3.80 | −0.42 | −1.45 | −0.75 | −1.2 | −1.21 | −1.25 |
| Change in laboratory-measured FPG (mmol/L) between BL and month 12 | −1.6 | −1.4 | −0.8 | −1.0 | −3.16 | −3.23 | −0.43 | −1.39 | −0.8 | −0.4 | −0.7 | −1.0 |
| Change in preinjection SMPG between BL and month 6 (mmol/L), LS mean change | −0.90 | −0.84 | −0.78 | −0.57 | −2.16 | −2.33 | −1.17 | −0.82 | −0.60 | 0.40 | 0.70 | 0.90 |
BL: baseline; FPG: fasting plasma glucose; Glar-100: insulin glargine 100 U/mL; Glar-300: insulin glargine 300 U/mL; LS: least squares; NS: not significant; SMPG: self-monitored plasma glucose.