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

Ariel Zisman, Terry Dex, Michelle Roberts, Aramesh Saremi, Jason Chao, Vanita R Aroda, Ariel Zisman, Terry Dex, Michelle Roberts, Aramesh Saremi, Jason Chao, Vanita R Aroda

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 A1c 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.

Keywords: Bedtime-to-morning glucose differential (BeAM); Fasting plasma glucose; Glycated hemoglobin A1c; Postprandial glucose; Postprandial hyperglycemia; Type 2 diabetes; iGlarLixi.

Figures

Fig. 1
Fig. 1
a Patients achieving target A1C and composite endpoints at week 30. b A1C change from baseline at week 30. c Documented symptomatic hypoglycemia event rate by week 30 BeAM values (< 55 mg/dL vs ≥ 55 mg/dL). For conversion of mg/dL to mmol/L use the following formula: mmol/L = (mg/dL)/18. A1C glycated hemoglobin A1c, BeAM bedtime-to-morning glucose differential, iGlar insulin glargine 100 U/mL, iGlarLixi a once-daily titratable fixed-ratio combination of iGlar and lixisenatide

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Source: PubMed

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