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Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The LixiLan JP-O2 Randomized Clinical Trial.
Diabetes Obes Metab. 2020 Apr 14 [Online ahead of print]DO

Abstract

AIMS

To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs).

MATERIALS AND METHODS

This phase 3, multicenter, open label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26.

RESULTS

Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m2 , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]). Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs. 38.5%, P < 0.0001), with significantly lower weight gain (LS mean difference - 1.06 kg, P < 0.0001). Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs.

CONCLUSIONS

HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c <7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs. Clinical Trial Number: NCT02752828. This article is protected by copyright. All rights reserved.

Authors+Show Affiliations

Department of Endocrinology and Metabolism, Graduate School of Medicine, Yokohama City University, Yokohama, Japan.Research & Development, Sanofi K.K, Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.Research & Development, Sanofi K.K, Tokyo, Japan.Research & Development, Sanofi K.K, Tokyo, Japan.Diabetes, Cardiovascular and Metabolics Development, Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32291880

Citation

Terauchi, Yasuo, et al. "Efficacy and Safety of Insulin Glargine/lixisenatide Fixed-ratio Combination (iGlarLixi 1:1) in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Oral Antidiabetic Drugs: a Randomized, 26-week, Open-label, Multicenter Study: the LixiLan JP-O2 Randomized Clinical Trial." Diabetes, Obesity & Metabolism, 2020.
Terauchi Y, Nakama T, Spranger R, et al. Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The LixiLan JP-O2 Randomized Clinical Trial. Diabetes Obes Metab. 2020.
Terauchi, Y., Nakama, T., Spranger, R., Amano, A., Inoue, T., & Niemoeller, E. (2020). Efficacy and safety of insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The LixiLan JP-O2 Randomized Clinical Trial. Diabetes, Obesity & Metabolism. https://doi.org/10.1111/dom.14036
Terauchi Y, et al. Efficacy and Safety of Insulin Glargine/lixisenatide Fixed-ratio Combination (iGlarLixi 1:1) in Japanese Patients With Type 2 Diabetes Mellitus Inadequately Controlled On Oral Antidiabetic Drugs: a Randomized, 26-week, Open-label, Multicenter Study: the LixiLan JP-O2 Randomized Clinical Trial. Diabetes Obes Metab. 2020 Apr 14; PubMed PMID: 32291880.
* 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 1:1) in Japanese patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs: A randomized, 26-week, open-label, multicenter study: The LixiLan JP-O2 Randomized Clinical Trial. AU - Terauchi,Yasuo, AU - Nakama,Takahiro, AU - Spranger,Robert, AU - Amano,Atsushi, AU - Inoue,Takahiro, AU - Niemoeller,Elisabeth, Y1 - 2020/04/14/ PY - 2019/12/13/received PY - 2020/03/17/revised PY - 2020/03/17/accepted PY - 2020/4/16/pubmed PY - 2020/4/16/medline PY - 2020/4/16/entrez KW - GLP-1 analogue KW - basal insulin KW - glycemic control KW - phase 3 study KW - type 2 diabetes JF - Diabetes, obesity & metabolism JO - Diabetes Obes Metab N2 - AIMS: To assess efficacy and safety of 26-week treatment with insulin glargine/lixisenatide fixed-ratio combination (iGlarLixi) compared with insulin glargine U100 (iGlar) in Japanese patients with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OADs). MATERIALS AND METHODS: This phase 3, multicenter, open label, 1:1 randomized, parallel-group study compared efficacy of iGlarLixi and iGlar in patients with T2DM, HbA1c of ≥7.5% to ≤9.5% and fasting plasma glucose ≤10.0 mmol/L (180 mg/dL). The primary endpoint was change in HbA1c from baseline to week 26. RESULTS: Patients were randomized to iGlarLixi (n = 260) or iGlar (n = 261) (mean age 59.7 years, baseline BMI 26.04 kg/m2 , and HbA1c 8.04% [64.4 mmol/mol]). HbA1c reduction was significantly greater with iGlarLixi (-1.40% [-15.3 mmol/mol]) than with iGlar (-0.76% [-8.3 mmol/mol]). Significantly more iGlarLixi patients reached HbA1c <7% at week 26 (71.5% vs. 38.5%, P < 0.0001), with significantly lower weight gain (LS mean difference - 1.06 kg, P < 0.0001). Documented symptomatic hypoglycemia (plasma glucose ≤3.9 mmol/L [70 mg/dL]) was recorded in 14.2% of patients with iGlarLixi and 12.3% with iGlar. No severe hypoglycemia was reported in either group. Other than the expected gastrointestinal issues associated with glucagon-like peptide 1 receptor agonists, we found no major difference in the incidence of TEAEs. CONCLUSIONS: HbA1c reduction was significantly greater with iGlarLixi than with iGlar; significantly more patients achieved HbA1c <7%, with no additional risk of hypoglycemia and without weight gain. iGlarLixi (1:1) provided an effective treatment option for Japanese patients with T2DM inadequately controlled on OADs. Clinical Trial Number: NCT02752828. This article is protected by copyright. All rights reserved. SN - 1463-1326 UR - https://www.unboundmedicine.com/medline/citation/32291880/Efficacy_and_safety_of_insulin_glargine/lixisenatide_fixed-ratio_combination_(iGlarLixi_1:1)_in_Japanese_patients_with_type_2_diabetes_mellitus_inadequately_controlled_on_oral_antidiabetic_drugs:_A_randomized,_26-week,_open-label,_multicenter_study:_The_LixiLan_JP-O2_Randomized_Clinical_Trial L2 - https://doi.org/10.1111/dom.14036 DB - PRIME DP - Unbound Medicine ER -
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