Dataset Information

Bedtime-to-Morning Glucose Difference and iGlarLixi in Type 2 Diabetes: Post Hoc Analysis of LixiLan-L.

ABSTRACT:

Introduction

A difference of ≥ 50-55 mg/dL between bedtime and morning glucose (BeAM) values in patients with type 2 diabetes (T2D) on basal insulin is an indicator of poor postprandial glucose control. This analysis compared the effect of treatment with a fixed-ratio combination of insulin glargine/lixisenatide (iGlarLixi) vs insulin glargine (iGlar) on BeAM values, and evaluated the impact of BeAM values on glycemic and safety endpoints.

Methods

In this post hoc analysis of 517 participants from the LixiLan-L trial, change in BeAM values and composite efficacy and safety endpoints stratified by BeAM value < 55 mg/dL or ≥ 55 mg/dL were evaluated in patients with T2D uncontrolled on basal insulin randomized to iGlarLixi or iGlar over 30 weeks (LixiLan-L).

Results

Greater reductions in BeAM values were seen with iGlarLixi vs iGlar, and a higher proportion of patients reached a BeAM value < 55 mg/dL in the iGlarLixi arm. A BeAM value < 55 mg/dL was associated with improved glycemic control, lower risk of hypoglycemia, and a greater proportion of patients achieving glycemic targets without hypoglycemia or weight gain. Greater reductions in BeAM values were seen with iGlarLixi vs iGlar, irrespective of stratification by glycated hemoglobin A_1c or glycemic endpoints.

Conclusions

Greater reductions in bedtime-to-morning glucose differential, or BeAM, were observed with iGlarLixi vs iGlar in patients with T2D uncontrolled on basal insulin, reflecting better overall control of both fasting and prandial glucose and more appropriate matching of therapy to physiologic needs.

Trial registration

ClinicalTrials.gov Identifier NCT02058160.

Funding

Sanofi US, Inc.

SUBMITTER: Zisman A

PROVIDER: S-EPMC6167304 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description: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 (HbA1c) levels from screening, both for the overall category and for screening HbA1c 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 HbA1c from screening to Week 30, patients reaching HbA1c < 7% at Week 30, and iGlar and lixisenatide (Lixi) doses at Week 30 overall and according to HbA1c subcategory at screening (HbA1c ≤ 8%, 8% < HbA1c ≤ 9%, and HbA1c > 9%). Documented symptomatic hypoglycemia during the treatment period was also assessed. RESULTS:HbA1c 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 (HbA1c ≤ 8%, 8% < HbA1c ≤ 9%, and HbA1c > 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 HbA1c level for iGlarLixi across all groups was < 7%. More patients achieved an HbA1c 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 HbA1c corresponded with a greater mean reduction in HbA1c for both treatment strategies. In all HbA1c screening categories, the risk of hypoglycemia was not increased with iGlarLixi versus iGlar during the treatment phase. CONCLUSION:iGlarLixi controlled HbA1c levels more effectively than iGlar across all HbA1c screening subgroups and in the overall study population without increasing the risk of hypoglycemia. TRIAL REGISTRATION:Clinicaltrials.gov Identifier: NCT02058160. FUNDING:Sanofi.