Lixisenatide reduces glycaemic variability in insulin‐treated patients with type 2 diabetes |
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| Authors: | Guillermo E. Umpierrez MD CDE David O'Neal MD Andres DiGenio MD PhD Ronald Goldenberg MD Eric Hernandez‐Triana MD Jay Lin PhD Cheol‐Young Park MD PhD Eric Renard MD PhD Boris Kovatchev PhD |
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| Affiliation: | 1. Department of Medicine, Emory University of Medicine, Atlanta, Georgia;2. University of Melbourne, Department of Medicine, St Vincent's Hospital, Melbourne, Australia;3. AKCEA Therapeutics, Cambridge, Massachusetts;4. LMC Diabetes and Endocrinology, Thornhill, Ontario, Canada;5. Endocare Research Institute, Universidad del Rosario, Bogota, Colombia;6. Novosys Health, Green Brook, New Jersey;7. Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea;8. Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France;9. INSERM Clinical Investigation Centre 1411, Montpellier, France;10. Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France;11. Center for Diabetes Technology, University of Virginia Health System, Charlottesville, Virginia |
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| Abstract: | Chronic hyperglycaemia and glucose variability are associated with the development of chronic diabetes‐related complications. We conducted a pooled analysis of patient‐level data from three 24‐week, randomized, phase III clinical trials to evaluate the impact of lixisenatide (LIXI) on glycaemic variability (GV) vs placebo as add‐on to basal insulin. The main outcome GV measures were standard deviation (s.d.), mean amplitude of glycaemic excursions (MAGE), mean absolute glucose (MAG) level, area under the curve for fasting glucose (AUC‐F), and high (HBGI) and low blood glucose index (LBGI). The change in GV metrics over 24 weeks and relationships among baseline GV, patient characteristics and outcomes were assessed. Data were pooled from 1198 patients (665 LIXI, 533 placebo). Values for s.d., MAG level, MAGE, HBGI, and AUC‐F significantly decreased with LIXI vs placebo, while LBGI values were unchanged. Higher baseline GV measures correlated with older age, longer type 2 diabetes duration, lower body mass index, higher baseline glycated/haemogobin, greater reduction in postprandial glucose (PPG) level, and higher rates of symptomatic hypoglycaemia. These data show that LIXI added to basal insulin significantly reduced GV and PPG excursions vs placebo, without increasing the risk of hypoglycaemia (LBGI). |
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| Keywords: | glycaemic variability insulin lixisenatide type 2 diabetes |
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