Table 2.
Adjusted means for the change from baseline at week 24 in HbA1c and fasting plasma glucose (full analysis set, last observation carried forward)
| Linagliptin | Placebo | |
|---|---|---|
| HbA1c | ||
| Patients*, n | 179 | 89 |
| Mean at baseline, mmol/mol (se) | 68 (1) | 69 (1) |
| Change from baseline, mmol/mol (se) | –10 (1) | –4 (1) |
| Adjusted† mean change from baseline, mmol/mol (se) | –9 (1) | –3 (2) |
| Difference vs. placebo | ||
| Adjusted† mean, mmol/mol (se) | –6 (1) | |
| 95% CI | –9 to –3 | |
| P-value | < 0.0001 | |
| Mean at baseline, % (se) | 8.39 (0.06) | 8.47 (0.08) |
| Change from baseline, % (se) | –0.92 (0.08) | –0.40 (0.12) |
| Adjusted† mean change from baseline, % (se) | –0.84 (0.11) | –0.27 (0.13) |
| Difference vs. placebo | ||
| Adjusted† mean, % (se) | –0.57 (0.13) | |
| 95% CI | –0.83 to –0.31 | |
| P-value | < 0.0001 | |
| Fasting plasma glucose | ||
| Patients*, n | 175 | 86 |
| Mean at baseline, mmol/l (se) | 8.26 (0.19) | 8.39 (0.27) |
| Change from baseline, mmol/l (se) | –0.55 (0.18) | –0.04 (0.26) |
| Adjusted‡ mean change from baseline, mmol/l (se) | –0.57 (0.15) | 0.00 (0.21) |
| Difference vs. placebo | ||
| Adjusted‡ mean, mmol/l (se) | –0.57 (0.26) | |
| 95% CI | –1.08 to –0.06 | |
| P-value | 0.0280 | |
| Mean at baseline, mg/dl (se) | 148.9 (3.5) | 151.3 (4.9) |
| Change from baseline, mg/dl (se) | –9.9 (3.2) | –0.7 (4.8) |
| Adjusted‡ mean change from baseline, mg/dl (se) | –10.3 (2.7) | 0.1 (3.8) |
| Difference vs. placebo | ||
| Adjusted‡ mean, mg/dl (se) | –10.4 (4.7) | |
| 95% CI | –19.6 to –1.1 | |
| P-value | 0.0280 | |
*
All patients who had a baseline and ≥ 1 on-treatment HbA1c measurement.
†
Adjusted model includes treatment, baseline HbA1c and centre as random.
‡
Adjusted model includes treatment, baseline HbA1c, baseline fasting plasma glucose and centre as random.