Table 5.
GetGoal clinical trial program
| Study design (n) | Weeks | Non-inferior HbA1C | Other important points regarding confirmed hypoglycemia and weight change |
|---|---|---|---|
| GetGoal Duo 1 [24]: double-blind, parallel group trial in which patients not achieving target HbA1C of <7% with insulin glargine were given lixisenatide or placebo as add on therapy (446) | 24 |
Adding lixisenatide to insulin glargine further reduced HbA1C by 0.71% versus 0.40% with placebo (p < 0.0001) More participants attained HbA1C 7% with lixisenatide (56% versus 39%; p < 0.0001) |
Lixisenatide reduced 2 h PPG more than placebo (p < 0.0001) Lixisenatide had a favorable effect on body weight (−0.89 kg compared to placebo; p = 0.0012) Nausea, vomiting, and symptomatic hypoglycemia (3.3 mmol/L) were more common with lixisenatide |
| GetGoal-M [25]: double-blind placebo-controlled study where the patients were randomized to receive injections of lixisenatide in the morning, lixisenatide in the evening, placebo in the morning, or placebo in the evening (680) | 24 | From a baseline HbA1C of 8.1%, administration of lixisenatide led to a decrease of −0.9% (morning injection) and −0.8% (evening injection) versus −0.4% with placebo (primary end point) at 24 weeks |
Mild and transient nausea and vomiting were the most commonly reported and only notable treatment emergent adverse events Hypoglycemia frequency was slightly higher in the lixisenatide groups versus placebo, but remained low with no cases of severe hypoglycemia |
| GetGoal-L [26]: efficacy and safety of lixisenatide as an add-on therapy to basal insulin was investigated in patients inadequately controlled on a combination of basal insulin ± metformin (495) | 24 | Lixisenatide significantly reduced HbA1C by −0.7 ± 0.1% versus −0.4 ± 0.1% with placebo at 24 weeks (p = 0.0002) and increased the proportion of patients achieving HbA1C <7% (28.0% versus 12.0% for placebo; p < 0.0001) |
Lixisenatide reduced body weight compared with placebo (p < 0.0001). A decrease in insulin dose at study end was seen with lixisenatide compared with placebo (−5.6 versus −1.9 U; p = 0.012) Incidence of symptomatic hypoglycemia was comparable (27.7% for lixisenatide versus 21.6% for placebo), whereas four cases of severe hypoglycemia occurred in the lixisenatide group compared to none in the placebo group |
| GetGoal-L-Asia [27]: adults previously treated and inadequately controlled with basal insulin ± sulfonylurea and were randomized on lixisenatide or placebo (311) | 24 | Lixisenatide significantly improved HbA1C by −0.88% compared to placebo (p < 0.0001) and more patients treated with lixisenatide achieved HbA1C of <7% compared to placebo (35.6% versus 5.2%; p < 0.0001) |
There was a trend in weight decreases in patients treated with lixisenatide, with no statistically significant differences between lixisenatide and placebo Symptomatic hypoglycemia was similar in patients not receiving sulfonylureas, but was more frequent with lixisenatide versus placebo (32.6 versus 28.3%) |
PPG postprandial plasma glucose