Table 6.
| Trial | Study drug | Lixisenatide outcomes vs comparator drugs |
|---|---|---|
| GETGOAL-Mono | Lixisenatide 1-step AM vs 2-step AM vs placebo; 12-week study | HbA1c: −0.66% 1-step vs −0.54% 2-step Achieved HbA1c goal (<7%): 46.5% 1-step vs 52.2% 2-step Decrease in body weight: ∼2 kg in both groups Symptomatic hypoglycemia: 1.7% in lixisenatide groups vs 1.6% in placebo groups Significant improvements in HbA1c: 2-hr PPG, FPG vs placebo |
| GETGOAL-F1 | Lixisenatide 1-step AM vs 2-step AM; all concurrently taking metformin; 24-week study | HbA1c: −0.9% vs −0.8% vs −0.4% Improved FPG: −0.5 vs −0.6 vs +0.1 mmol/L Body weight: −2.6 kg vs −2.7 kg vs −1.6 kg Symptomatic hypoglycemia: 1.9% vs 2.5% vs 0.6% |
| GETGOAL-S | Lixisenatide 2-step AM vs placebo; all concurrently taking sulfonylurea; 24-week study | HbA1c: −1.1% mean significant difference vs placebo Significant 2-hr postprandial glucose & FPG vs placebo Body weight: −1.12 kg vs −1.02 kg GI adverse effects: 52.6% vs 29.4% Symptomatic hypoglycemia: 17.1% vs 9.8% No cases of severe symptomatic hypoglycemia in either group |
| GETGOAL-L | Lixisenatide 2-step AM vs placebo; all concurrently taking basal insulin | HbA1c reduction: −0.4% difference vs placebo Symptomatic hypoglycemia: 28% vs 22% Severe hypoglycemia: 1.2% vs 0% |
| GETGOAL-P | Lixisenatide 2-step AM vs placebo; all concurrently taking pioglitazone; 24-week study | HbA1c reduction: −0.56% difference vs placebo Significantly improved FPG: −0.84 mmol/L Small decrease body weight w/ lixisenatide & small but insignificant increase w/ placebo Symptomatic hypoglycemia: 3.4% vs 1.2%; no severe episodes |
| GETGOAL-X | Lixisenatide 2-step AM vs exenatide 10 mcg twice daily; all concurrently taking metformin; 24-week study | Noninferiority in HbA1c reduction vs exenatide FPG reduction was comparable Weight loss: −2.8 kg vs −3.8 kg Serious adverse events: 2.8% vs 2.2% Significantly reduced symptomatic hypoglycemia: 2.5% vs 7.9% Significantly less nausea events: 24.5% vs 35.1% |
| GETGOAL-M | Lixisenatide 2-step AM or PM vs placebo; all concurrently taking metformin; 24-week study (similar to GETGOAL-F1) | Significant HbA1c reduction: −0.36% difference vs placebo Significant reduction in 2-hr PPG vs placebo No difference in weight loss Nausea: 16.3% vs 2.6% Symptomatic hypoglycemia: 5.6% vs 2.6% No severe symptomatic hypoglycemia |
| GETGOAL-Mono JAPAN LTS | Lixisenatide 1-step AM vs 2-step AM; 52-week study with primary end point on safety measures | Nausea: 59% vs 36.4% Symptomatic hypoglycemia: 0% vs 6.1% HbA1c, FPG, body weight reduced from baseline |
| GETGOAL-L-ASIA | Lixisenatide 2-step AM vs placebo; all concurrently taking basal insulin; 24-week study (similar to GETGOAL-S) | HbA1c reduction: −0.88% vs placebo Significant improvement in 2-hr postprandial glucose Nausea and vomiting: 18.2% vs 1.9% Symptomatic hypoglycemia: 42.9% vs 23.6% No severe hypoglycemia |
| GETGOAL-M-ASIA | Lixisenatide 2-step AM vs placebo; all concurrently taking metformin + sulfonylurea; 24-week study | HbA1c reduction: −0.57% (significant difference) Superior to placebo in lowering 2-hr postprandial glucose Body weight in lixisenatide group trended to decrease |
AM indicates morning administration; FPG, fasting plasma glucose; GI, gastrointestinal; HbA1c, glycated hemoglobin; PM, evening administration; PPG, postprandial plasma glucose.