Table 2.
Comparison of the outcome (mean, 90% CI) of the placebo-corrected QTc (as well as uncorrected QT interval and heart rate) change from baseline for linagliptin 5 mg and 100 mg, and moxifloxacin 400 mg over time
| Linagliptin 5 mg (n = 43) | |||||
|---|---|---|---|---|---|
| Time (h) | QTcI (ms) | QTcN (ms) | QTcF (ms) | QT (ms) | HR (beats min−1) |
| 0.5 | 0.0 (–2.0, 2.0) | 0.3 (–1.5, 2.1) | 0.8 (–1.2, 2.8) | –0.3 (–2.8, 2.2) | 0.6 (–0.7, 1.8) |
| 1 | 0.2 (–2.0, 2.4) | 0.1 (–1.9, 2.2) | 1.3 (–0.8, 3.4) | –1.4 (–4.3, 1.5) | 1.3 (0.0, 2.6) |
| 1.5 | –0.4 (–2.7, 1.9) | –0.1 (–2.3, 2.1) | –0.1 (–2.2, 1.9) | 0.1 (–3.2, 3.4) | 0.0 (–1.3, 1.4) |
| 2 | –2.0 (–4.3, 0.3) | –2.4 (–4.5, −0.2) | –1.6 (–3.8, 0.6) | –3.3 (–6.4, −0.2) | 0.9 (–0.4, 2.1) |
| 3 | –1.0 (–3.4, 1.3) | –1.2 (–3.4, 1.1) | –0.9 (–3.0, 1.2) | –1.4 (–4.6, 1.8) | 0.4 (–0.7, 1.4) |
| 4 | –1.8 (–4.4, 0.7) | –1.8 (–4.2, 0.7) | –1.9 (–4.1, 0.3) | –1.4 (–5.0, 2.1) | –0.3 (–1.4, 0.9) |
| 6 | –0.9 (–3.8, 2.0) | –0.3 (–2.6, 2.1) | 0.9 (–1.2, 3.0) | –1.8 (–5.5, 1.9) | 1.2 (–0.4, 2.8) |
| 8 | –0.7 (–3.3, 1.9) | –0.6 (–2.9, 1.6) | 0.4 (–1.7, 2.5) | –2.0 (–5.4, 1.5) | 1.1 (–0.4, 2.7) |
| 12 | –0.6 (–3.3, 2.0) | –0.6 (–3.1, 1.8) | –0.4 (–2.6, 1.7) | –0.7 (–4.3, 2.9) | 0.1 (–1.3, 1.6) |
| 24 | –1.8 (–3.9, 0.2) | –1.7 (–3.8, 0.4) | –1.8 (–3.7, 0.2) | –1.5 (–4.6, 1.6) | 0.0 (–1.3, 1.2) |
| Linagliptin 100 mg (n = 44) | |||||
|---|---|---|---|---|---|
| Time (h) | QTcI (ms) | QTcN (ms) | QTcF (ms) | QT (ms) | HR (beats min−1) |
| 0.5 | –1.2 (–3.2, 0.8) | –0.9 (–2.7, 0.9) | 1.6 (–0.4, 3.6) | –4.2 (–6.7, −1.7) | 3.1 (1.9, 4.3) |
| 1 | –1.8 (–3.9, 0.4) | –1.4 (–3.4, 0.6) | 1.8 (–0.3, 3.8) | –5.7 (–8.6, −2.9) | 4.0 (2.7, 5.3) |
| 1.5 | –1.4 (–3.7, 0.8) | –1.1 (–3.3, 1.2) | 1.0 (–1.1, 3.0) | –3.8 (–7.0, −0.5) | 2.7 (1.3, 4.1) |
| 2 | –2.0 (–4.3, 0.3) | –1.6 (–3.7, 0.6) | 1.1 (–1.1, 3.2) | –5.3 (–8.3, −2.2) | 3.2 (1.9, 4.5) |
| 3 | –2.0 (–4.3, 0.3) | –1.5 (–3.7, 0.8) | 0.8 (–1.3, 2.9) | –4.6 (–7.8, −1.4) | 2.6 (1.6, 3.7) |
| 4 | –4.7 (–7.2, −2.1) | –4.2 (–6.7, −1.8) | –2.8 (–5.0, −0.6) | –6.2 (–9.7, −2.7) | 1.7 (0.5, 2.8) |
| 6 | –0.9 (–3.8, 2.0) | 0.0 (–2.4, 2.3) | 1.4 (–0.6, 3.5) | –2.0 (–5.7, 1.7) | 1.9 (0.3, 3.5) |
| 8 | –2.6 (–5.2, 0.0) | –1.7 (–3.9, 0.5) | 0.8 (–1.2, 2.9) | –5.2 (–8.7, −1.7) | 3.2 (1.7, 4.8) |
| 12 | –2.5 (–5.1, 0.1) | –1.6 (–4.0, 0.8) | –0.9 (–3.1, 1.2) | –2.4 (–5.9, 1.2) | 1.0 (–0.4, 2.4) |
| 24 | –1.8 (–3.8, 0.3) | –1.4 (–3.5, 0.7) | –0.2 (–2.1, 1.8) | –3.0 (–6.1, 0.1) | 1.4 (0.2, 2.7) |
| Moxifloxacin 400 mg (n = 44) | |||||
|---|---|---|---|---|---|
| Time (h) | QTcI (ms) | QTcN (ms) | QTcF (ms) | QT (ms) | HR (beats min−1) |
| 0.5 | 0.0 (–2.0, 2.0) | 0.1 (–1.7, 1.9) | 0.6 (–1.3, 2.6) | –0.4 (–2.9, 2.1) | 0.5 (–0.7, 1.7) |
| 1 | 2.6 (0.4, 4.7) | 2.1 (0.1, 4.1) | 3.0 (0.9, 5.1) | 1.0 (–1.8, 3.9) | 1.0 (–0.3, 2.3) |
| 1.5 | 5.5 (3.2, 7.7) | 5.4 (3.1, 7.6) | 5.9 (3.9, 7.9) | 4.8 (1.5, 8.0) | 0.5 (–0.9, 1.9) |
| 2 | 6.7 (4.4, 9.0) | 6.3 (4.2, 8.5) | 8.1 (6.0, 10.3) | 3.9 (0.8, 7.0) | 1.8 (0.6, 3.1) |
| 3 | 10.4 (8.1, 12.7) | 10.5 (8.3, 12.8) | 11.5 (9.4, 13.6) | 9.4 (6.2, 12.6) | 0.9 (–0.1, 2.0) |
| 4 | 10.3 (7.7, 12.8) | 10.1 (7.6, 12.5) | 11.0 (8.8, 13.2) | 8.9 (5.4, 12.5) | 1.0 (–0.2, 2.1) |
| 6 | 7.3 (4.4, 10.2) | 7.8 (5.4, 10.2) | 8.3 (6.2, 10.4) | 7.2 (3.6, 10.9) | 0.4 (–1.2, 2.0) |
| 8 | 6.7 (4.1, 9.3) | 7.0 (4.8, 9.3) | 8.8 (6.7, 10.8) | 4.8 (1.3, 8.2) | 1.8 (0.3, 3.4) |
| 12 | 6.7 (4.1, 9.4) | 7.0 (4.6, 9.5) | 7.6 (5.5, 9.7) | 6.5 (2.9, 10.1) | 0.4 (–1.0, 1.8) |
| 24 | 2.5 (0.5, 4.6) | 2.2 (0.1, 4.3) | 2.4 (0.5, 4.3) | 2.1 (–0.9, 5.2) | 0.0 (–1.3, 1.2) |