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Journal

Beneficial effects of once–daily lixisenatide on overall and postprandial glycemic levels without significant excess of hypoglycemia in Type 2 diabetes inadequately controlled on a sulfonylurea with or without metformin (GetGoal–S)

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Published:25th Mar 2020

Aims:

To assess efficacy and safety of lixisenatide once–daily versus placebo in Type 2 diabetes mellitus (T2DM) patients inadequately controlled on sulfonylurea (SU)±metformin.

Methods:

In this randomized, double–blind, two–arm, parallel–group, multicenter study, patients received lixisenatide 20μg once–daily or placebo for 24 weeks in a stepwise dose increase on top of SUs±metformin. Primary outcome was change in HbA1C from baseline to Week 24.

Results:

Lixisenatide provided a significant reduction in HbA1C at Week 24 versus placebo (LS mean: –0.85% vs –0.10%; p<0.0001) and more patients achieved hba>1C <7.0% (36.4% vs 13.5%; p><0.0001). lixisenatide significantly lowered fpg and body weight versus placebo. in breakfast meal test patients, lixisenatide reduced 2–hour ppg versus placebo (ls mean: –111.48 vs –3.80mg dl [–6.19 vs –0.21mmol l]; p><0.0001) and glucose excursion (–94.11 vs +6.24mg dl [–5.22 vs +0.35mmol l]), and reduced 2–hour glucagon, insulin, proinsulin, and c–peptide. the percentage of aes was 68.3% for lixisenatide and 61.1% for placebo; and for saes: 3.5% versus 5.6%, respectively. lixisenatide did not significantly increase symptomatic hypoglycemia versus placebo (15.3% vs 12.3%, respectively); one severe episode of hypoglycemia was reported with lixisenatide.>

Conclusions:

Once–daily lixisenatide significantly improved glycemic control, with a pronounced postprandial effect, without significant increase in symptomatic/severe hypoglycemia risk and with weight loss over 24 weeks.

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