Table 2.
Categorical secondary outcomes: proportions of patients achieving HbA1c levels < 7.0% and < 8.0% at T0 and T6 (EP and PP populations)
| Population | Outcome | T0 (%) | T6 (%) | Absolute pre–post difference (%) | p-valuea |
|---|---|---|---|---|---|
| EP | HbA1c < 7.0% | 5.4 | 16.3 | + 10.9 | 0.0001 |
| PP | HbA1c < 7.0% | 7.7 | 19.7 | + 12.0 | 0.002 |
| EP | HbA1c < 8.0% | 25.5 | 53.8 | + 28.3 | < 0.0001 |
| PP | HbA1c < 8.0% | 29.1 | 59.8 | + 30.7 | < 0.0001 |
aMcNemar test. Statistically significant p-values (p < 0.05) are in bold
EP efficacy population: subset of the intention-to-treat population (ITT) having HbA1c valid values at T0 and T6; PP per-protocol population: subset of EP patients treated according to summary of product characteristics