Table 2.
Efficacy outcomes from the GetGoal study program
| Study | HbA1c LS mean difference (Lixi vs placebo) | FPG LS mean difference (Lixi vs placebo) | 2-hour PPG LS mean difference (Lixi vs placebo) | Weight LS mean difference (Lixi vs placebo) |
|---|---|---|---|---|
| GetGoal-Mono53 | ||||
| One-step doses titration | −0.66% (P < 0.01) | −1.1 mmol/L (P < 0.01) | −4.8 mmol/L (−6.3; −3.4) | ~0.0 kg |
| Two-step doses titration | −0.54% (P < 0.01) | −0.9 mmol/L (P < 0.01) | −3.9 mmol/L (−5.4; −2.4) | ~0.0 kg |
| GetGoal-P59 | −0.56% (−0.73; −0.39) | −0.8 mmol/L (−1.2; −0.5) | −0.4 kg (−1.0; 0.2) | |
| GetGoal-L47 | −0.36% (−0.55; −0.17) | −3.8 mmol/L (−4.7; −2.9) | −1.3 kg (−1.8; −0.8) | |
| GetGoal-S56 | −0.74% (−0.87; −0.62) | −0.6 mmol/L (P < 0.01) | −6.0 mmol/L (−6.9; −5.0) | −0.8 kg (P < 0.01) |
| GetGoal-M51 | ||||
| AM administration | −0.49% (P < 0.01) | −0.9 mmol/L (P < 0.05) | −4.5 mmol/L (−5.7; −3.4) | −0.4 kg (P > 0.05) |
| PM administration | −0.37% (P < 0.01) | −0.6 mmol/L (P < 0.05) | −0.4 kg (P > 0.05) | |
| GetGoal-F155,58 | ||||
| One-step doses titration | −0.49% (P < 0.01) | 0.7 mmol/L (P < 0.01) | −1.0 kg (P < 0.01) | |
| Two-step doses titration | −0.41% (P < 0.01) | −0.7 mmol/L (P < 0.01) | −1.1 kg (P < 0.01) | |
| GetGoal-L-Asia48 | −0.88% (−1.12; −0.65) | −0.7 mmol/L (P < 0.05) | −7.8 mmol/L (−8.9; −6.8) | −0.4 kg (−0.9; 0.1) |
| GetGoal-Duo 146 | −0.32% (−0.46; −0.17) | −0.1 mmol/L (−0.5; 0.2) | −3.2 mmol/L (−4.0; −2.4) | −0.9 kg (−1.4; −0.4) |
| Lixi vs exenatide | Lixi vs exenatide | Lixi vs exenatide | Lixi vs exenatide | |
|
| ||||
| GetGoal-X49 | 0.17% (0.03; 0.30) | 0.2 mmol/L (−0.1; 0.5) | 1.0 kg (0.5; 1.6) | |
Notes: One-step titration: 10 μg once daily for 1 week (GetGoal-Mono) or 2 weeks (GetGoal-F1), before reaching the target dose of 20 μg; two-step titration: 10 μg once daily for 1 week followed by 15 μg for 1 week, before reaching the target dose of 20 μg. The listed confidence intervals are at the 95% level. A lixisenatide target dose of 20 μg once daily was used in all studies. The GetGoal-X study applied an exenatide target dose of 10 μg twice daily.
Abbreviations: 2-hour PPG, postprandial plasma glucose 2 hours after a standardized test meal; AM, morning; FPG, fasting plasma glucose; HbA1c, glycated hemoglobin; lixi, lixisenatide; LS, least squares; PM, evening; vs, versus.