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iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L.
Diabetes Ther. 2018 Feb; 9(1):373-382.DT

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 (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.

Authors+Show Affiliations

Sanofi, Frankfurt, Germany. Elisabeth.Niemoeller@sanofi.com.Sanofi, Paris, France.Sanofi, Bridgewater, NJ, USA.Sanofi, Frankfurt, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

29143919

Citation

Niemoeller, Elisabeth, et al. "IGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L." Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, vol. 9, no. 1, 2018, pp. 373-382.
Niemoeller E, Souhami E, Wu Y, et al. IGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes therapy : research, treatment and education of diabetes and related disorders. 2018;9(1):373-382.
Niemoeller, E., Souhami, E., Wu, Y., & Jensen, K. H. (2018). IGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes Therapy : Research, Treatment and Education of Diabetes and Related Disorders, 9(1), 373-382. https://doi.org/10.1007/s13300-017-0336-6
Niemoeller E, et al. IGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. Diabetes therapy : research, treatment and education of diabetes and related disorders. 2018;9(1):373-382. PubMed PMID: 29143919.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - iGlarLixi Reduces Glycated Hemoglobin to a Greater Extent Than Basal Insulin Regardless of Levels at Screening: Post Hoc Analysis of LixiLan-L. AU - Niemoeller,Elisabeth, AU - Souhami,Elisabeth, AU - Wu,Yujun, AU - Jensen,Klaus H, Y1 - 2017/11/16/ PY - 2017/08/29/received PY - 2017/11/17/pubmed PY - 2017/11/17/medline PY - 2017/11/17/entrez KW - Glycated hemoglobin KW - Insulin glargine U100 KW - Lixisenatide KW - Type 2 diabetes KW - iGlarLixi SP - 373 EP - 382 JF - Diabetes therapy : research, treatment and education of diabetes and related disorders VL - 9 IS - 1 N2 - 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. SN - 1869-6953 UR - https://www.unboundmedicine.com/medline/citation/29143919/iGlarLixi_Reduces_Glycated_Hemoglobin_to_a_Greater_Extent_Than_Basal_Insulin_Regardless_of_Levels_at_Screening:_Post_Hoc_Analysis_of_LixiLan_L_ L2 - https://dx.doi.org/10.1007/s13300-017-0336-6 DB - PRIME DP - Unbound Medicine ER -
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