Abstract
INTRODUCTION: The 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. METHODS: This 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) < 7% at Week 30, and iGlar and lixisenatide (Lixi) doses at Week 30 overall and according to HbA(1c) subcategory at screening (HbA(1c) ≤ 8%, 8% < HbA(1c) ≤ 9%, and HbA(1c) > 9%). Documented symptomatic hypoglycemia during the treatment period was also assessed. RESULTS: HbA(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% < HbA(1c) ≤ 9%, and HbA(1c) > 9%): - 1.1, - 1.4, - 2.4 (iGlarLixi) vs. - 0.5, - 1.0, - 1.8% (iGlar), respectively (all p < 0.0001). The end-of-treatment mean HbA(1c) level for iGlarLixi across all groups was < 7%. More patients achieved an HbA(1c) of < 7% with iGlarLixi than with iGlar, both overall (59.9 vs. 31.2%) and within each subgroup [74.2, 54.7, 52.2 (iGlarLixi) vs. 37.2, 31.6, 23.5% (iGlar), respectively]. A higher initial screening HbA(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. CONCLUSION: iGlarLixi 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 REGISTRATION: Clinicaltrials.gov Identifier: NCT02058160. FUNDING: Sanofi.