iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L

摘要

IntroductionThe treatment of patients with type 2 diabetes uncontrolled on basal insulin and oral glucose-lowering drugs was investigated previously in the LixiLan-L trial. In the LixiLan-L trial, patients experienced a 6-week run-in with insulin glargine U100 (iGlar) as part of the screening phase, followed by treatment with a fixed-ratio combination of iGlar + lixisenatide (iGlarLixi) or iGlar alone over 30?weeks. In the study reported here, we investigated the achievement of glycemic control in those who completed the 30-week LixiLan-L trial, as assessed by change in glycated hemoglobin (HbA_1c) levels from screening, both for the overall category and for screening HbA_1c subcategories. MethodsThis post hoc analysis of the LixiLan-L trial included both the screening phase and the treatment period for 30-week completers and evaluated the change in HbA_1c from screening to Week 30, patients reaching HbA_1c?1c subcategory at screening (HbA_1c?≤?8%, 8%?1c?≤?9%, and HbA_1c?>?9%). Documented symptomatic hypoglycemia during the treatment period was also assessed. ResultsHbA_1c reductions (least squares mean) from screening to Week 30 were greater for iGlarLixi than iGlar, both overall (??1.7 vs. ??1.1%) and in all subgroups (HbA_1c?≤?8%, 8%?1c?≤?9%, and HbA_1c?>?9%): ??1.1, ??1.4, ??2.4 (iGlarLixi) vs. ??0.5, ??1.0, ??1.8% (iGlar), respectively (all p 1c level for iGlarLixi across all groups was?1c of?1c corresponded with a greater mean reduction in HbA_1c for both treatment strategies. In all HbA_1c screening categories, the risk of hypoglycemia was not increased with iGlarLixi versus iGlar during the treatment phase. ConclusioniGlarLixi controlled HbA_1c levels more effectively than iGlar across all HbA_1c screening subgroups and in the overall study population without increasing the risk of hypoglycemia. Trial RegistrationClinicaltrials.gov Identifier: NCT02058160. FundingSanofi.