Ítem
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Lixisenatide reduces glycaemic variability in insulin-treated patients with type 2 diabetes
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Autores
Umpierrez G.E.
O'Neal D.
DiGenio A.
Goldenberg R.
Hernandez-Triana E.
Lin J.
Park C.-Y.
Renard E.
Kovatchev B.
Fecha
2017
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Blackwell Publishing Ltd
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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). © 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley and Sons Ltd.
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Keywords
Glucose , type 2 , Insulin , Lixisenatide , Placebo , Antidiabetic agent , Glp1r protein , Glucagon like peptide 1 receptor , Glycosylated hemoglobin , Hemoglobin a1c protein , Insulin , Lixisenatide , Peptide , Article , Body mass , Clinical effectiveness , Clinical evaluation , Disease duration , Drug efficacy , Endocrine function , Follow up , Glucose blood level , Glycemic variability , Hemoglobin blood level , Human , Hypoglycemia , Major clinical study , Multicenter study (topic) , Non insulin dependent diabetes mellitus , Phase 3 clinical trial (topic) , Randomized controlled trial (topic) , Agonists , Analysis , Blood , Blood glucose monitoring , Chemically induced , Clinical trial , Cohort analysis , Combination drug therapy , Controlled study , Double blind procedure , Drug resistance , Hyperglycemia , Hypoglycemia , Intention to treat analysis , Metabolism , Middle aged , Non insulin dependent diabetes mellitus , Pathophysiology , Phase 3 clinical trial , Randomized controlled trial , Reproducibility , Severity of illness index , Blood glucose , Blood glucose self-monitoring , Cohort studies , Diabetes mellitus , Double-blind method , Drug resistance , Drug therapy , Follow-up studies , Glucagon-like peptide-1 receptor , Glycated hemoglobin a , Humans , Hyperglycemia , Hypoglycemia , Hypoglycemic agents , Insulin , Intention to treat analysis , Middle aged , Peptides , Reproducibility of results , Severity of illness index , Glycaemic variability , Insulin , Lixisenatide , Type 2 diabetes
