Efficacy and Safety of the Once-Daily GLP-1 Receptor Agonist Lixisenatide in Monotherapy: A randomized, double-blind, placebo-controlled trial in patients with type 2 diabetes (GetGoal-Mono)

Original Research

Efficacy and Safety of the Once-Daily GLP-1 Receptor Agonist Lixisenatide in Monotherapy

¹Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana
²Cardioprevent, Durango, Mexico
³Department of Diabetology, University Hospital Sainte Marguerite, Marseille, France
⁴Sanofi R&D, Chilly-Mazarin, France
⁵Sanofi R&D, Paris, France
⁶Department of Medicine, University of Rochester School of Medicine, Rochester, New York

Diabetes Care 2012 Jun; 35(6): 1225-1231. https://doi.org/10.2337/dc11-1935

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Figure 1
Changes in glycated hemoglobin (HbA_1c) levels after 12 weeks’ treatment with lixisenatide (according to dose increase regimen) or placebo. A: Mean change (±SEM) in HbA_1c over time. B: Percentage of patients achieving HbA_1c goals <7.0% and ≤6.5%. LOCF, Last Observation Carry Forward.
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Figure 2
Changes in postbreakfast glucose parameters from baseline after 12-weeks' treatment with lixisenatide (according to dose increase regimen) or placebo. LS mean change in mean (±SEM) 2-h PPG levels is shown. LS mean change in 2-h glucose excursion is also shown. Data are from patients undergoing a standardized breakfast meal test at selected sites. Glucose excursion = 2-h PPG, plasma glucose 30 min before the meal test before study drug administration. Mean ± SD baseline values for 2-h PPG: 13.99 ± 4.78 mmol/L (placebo), 14.67 ± 3.78 mmol/L (lixisenatide 2-step), 14.55 ± 3.36 mmol/L (lixisenatide 1-step). Mean ± SD baseline values for glucose excursion: 4.72 ± 3.65 mmol/L (placebo), 5.45 ± 3.02 mmol/L (lixisenatide 2-step), 5.25 ± 2.89 mmol/L (lixisenatide 1-step). To convert mmol/L to mg/dL, divide by 0.0555.