Table 3.
Safety and tolerability (safety population)
| Lixisenatide (n = 77) | Liraglutide (n = 71) | |
|---|---|---|
| Adverse event (AE), n (%) | ||
| Any AE | 45 (58.4) | 52 (73.2) |
| Any AE (excluding decreased appetite) | 42 (54.5) | 46 (64.8) |
| Serious AE | 0 | 0 |
| AE leading to death | 0 | 0 |
| AE leading to discontinuation | 2 (2.6) | 2 (2.8) |
| Any symptomatic hypoglycaemia* | 0 | 0 |
| Gastrointestinal disorders (any) | 28 (36.4) | 33 (46.5) |
| Nausea | 17 (22.1) | 16 (22.5) |
| Dyspepsia | 6 (7.8) | 12 (16.9) |
| Diarrhoea | 2 (2.6) | 11 (15.5) |
| Abdominal distension | 5 (6.5) | 9 (12.7) |
| Vomiting | 8 (10.4) | 5 (7.0) |
| Vital sign measurements | ||
| Δ heart rate, bpm [mean (95% CI)]† | −3.6 (−5.8, –1.3) | 5.3 (2.9, 7.7) |
| Treatment difference, mmHg (95% CI) | −8.9 (−12.2, –5.6) | |
| Δ ECG heart rate, bpm [mean (95% CI)]† | −3.4 (−5.6, –1.2) | 5.9 (3.6, 8.2) |
| Treatment difference, mmHg (95% CI) | −9.3 (−12.5, –6.1) | |
| Δ SBP, mmHg [mean (95% CI)]† | −2.0 (−4.9, 0.8) | −2.8 (−5.9, 0.2) |
| Treatment difference, mmHg (95% CI) | 0.8 (−3.3, 5.0) | |
| Δ DBP, mmHg [mean (95% CI)]† | −0.6 (−2.2, 1.1) | 1.1 (−0.7, 2.8) |
| Treatment difference, mmHg (95% CI) | −1.7 (−4.1, 0.7) | |
Δ, change from day −2 (baseline) to day 29; AE, adverse event; bpm, beats per minute; CI, confidence interval; DBP, diastolic blood pressure; SBP, systolic blood pressure.
*
Event with clinical symptoms with either plasma glucose <3.3 mmol/l or prompt recovery after oral carbohydrate administration if no plasma glucose measurement was available.
†
All measurements taken in the supine position (n = 76 for lixisenatide; n = 68 for liraglutide).