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Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L Randomized Clinical Trial.
Diabetes Obes Metab. 2020 Feb 19 [Online ahead of print]DO

Abstract

AIMS

To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin and oral antidiabetic drugs (OADs).

MATERIALS AND METHODS

This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs. 512 patients were randomized after a 12-week run-in, when iGlar was introduced and/or further titrated and OADs other than metformin were stopped. The primary endpoint was change in HbA1c from baseline to week 26.

RESULTS

iGlarLixi (n=255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n=257, -0.53%) (LS mean difference: -0.74%, P <0.0001) at week 26, confirming the superiority of iGlarLixi. Significantly more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs. 16.0% for iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51kg vs. +0.55kg). Documented symptomatic hypoglycemia (plasma glucose ≤3.9mmol/L) was observed in 18.8% of iGlarLixi patients vs. 16.7% of iGlar patients. iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs. 8.6%), primarily nausea (16.9% vs. 0.8%). However, the treatment was generally well-tolerated.

CONCLUSIONS

A once-daily injection of iGlarLixi with metformin is an effective, well-tolerated, and simple therapeutic intervention providing significant improvement in glycemic control in Japanese patients with T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial Number: NCT02752412 This article is protected by copyright. All rights reserved.

Authors+Show Affiliations

Department of Diabetes, Endocrinology and Metabolism, Kawasaki Medical School, Kurashiki, Japan.Research & Development, Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.Research & Development, Tokyo, Japan.Research & Development, Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32072742

Citation

Kaneto, Hideaki, et al. "Efficacy and Safety of Insulin Glargine/lixisenatide Fixed-ratio Combination (iGlarLixi) in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Basal Insulin and Oral Antidiabetic Drugs: the LixiLan JP-L Randomized Clinical Trial." Diabetes, Obesity & Metabolism, 2020.
Kaneto H, Takami A, Spranger R, et al. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L Randomized Clinical Trial. Diabetes Obes Metab. 2020.
Kaneto, H., Takami, A., Spranger, R., Amano, A., Watanabe, D., & Niemoeller, E. (2020). Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L Randomized Clinical Trial. Diabetes, Obesity & Metabolism. https://doi.org/10.1111/dom.14005
Kaneto H, et al. Efficacy and Safety of Insulin Glargine/lixisenatide Fixed-ratio Combination (iGlarLixi) in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Basal Insulin and Oral Antidiabetic Drugs: the LixiLan JP-L Randomized Clinical Trial. Diabetes Obes Metab. 2020 Feb 19; PubMed PMID: 32072742.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) in Japanese patients with type 2 diabetes mellitus inadequately controlled on basal insulin and oral antidiabetic drugs: The LixiLan JP-L Randomized Clinical Trial. AU - Kaneto,Hideaki, AU - Takami,Akane, AU - Spranger,Robert, AU - Amano,Atsushi, AU - Watanabe,Daisuke, AU - Niemoeller,Elisabeth, Y1 - 2020/02/19/ PY - 2019/12/13/received PY - 2020/02/06/revised PY - 2020/02/14/accepted PY - 2020/2/20/pubmed PY - 2020/2/20/medline PY - 2020/2/20/entrez KW - GLP-1 analogue KW - basal insulin KW - glycemic control KW - metformin KW - phase 3 study KW - type 2 diabetes JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab N2 - AIMS: To assess efficacy and safety of fixed-ratio (1:1) combination insulin glargine and lixisenatide (iGlarLixi) compared to insulin glargine U100 (iGlar), with metformin, in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on basal insulin and oral antidiabetic drugs (OADs). MATERIALS AND METHODS: This 26-week, randomized, open-label study compared iGlarLixi to iGlar, both with metformin in adult Japanese patients with T2DM and hemoglobin (Hb) A1c ≥7.5% to ≤9.5%, treated with basal insulin and 1 or 2 OADs. 512 patients were randomized after a 12-week run-in, when iGlar was introduced and/or further titrated and OADs other than metformin were stopped. The primary endpoint was change in HbA1c from baseline to week 26. RESULTS: iGlarLixi (n=255) demonstrated significantly greater reductions in HbA1c (-1.27%) than iGlar (n=257, -0.53%) (LS mean difference: -0.74%, P <0.0001) at week 26, confirming the superiority of iGlarLixi. Significantly more iGlarLixi patients reached target HbA1c <7% at week 26 (51.8% vs. 16.0% for iGlar). iGlarLixi patients lost weight in contrast to iGlar patients (-0.51kg vs. +0.55kg). Documented symptomatic hypoglycemia (plasma glucose ≤3.9mmol/L) was observed in 18.8% of iGlarLixi patients vs. 16.7% of iGlar patients. iGlarLixi patients had more gastrointestinal-related adverse events than iGlar patients (33.3% vs. 8.6%), primarily nausea (16.9% vs. 0.8%). However, the treatment was generally well-tolerated. CONCLUSIONS: A once-daily injection of iGlarLixi with metformin is an effective, well-tolerated, and simple therapeutic intervention providing significant improvement in glycemic control in Japanese patients with T2DM inadequately controlled on basal insulin and up to two OADs. Clinical Trial Number: NCT02752412 This article is protected by copyright. All rights reserved. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/32072742/Efficacy_and_safety_of_insulin_glargine/lixisenatide_fixed-ratio_combination_(iGlarLixi)_in_Japanese_patients_with_type_2_diabetes_mellitus_inadequately_controlled_on_basal_insulin_and_oral_antidiabetic_drugs:_The_LixiLan_JP-L_Randomized_Clinical_Trial L2 - https://doi.org/10.1111/dom.14005 DB - PRIME DP - Unbound Medicine ER -
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