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Efficacy and safety benefits of iGlarLixi versus insulin glargine 100 U/mL or lixisenatide in Asian Pacific people with suboptimally controlled type 2 diabetes on oral agents: The LixiLan-O-AP randomized controlled trial

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单位: [1]China Japan Friendship Hosp, 2 Yinghuayuan E St, Beijing 100029, Peoples R China [2]Jinan Cent Hosp, Jinan, Peoples R China [3]Zhengzhou Univ, Affiliated Hosp 2, Zhengzhou, Peoples R China [4]Harbin Med Univ, Affiliated Hosp 4, Harbin, Peoples R China [5]Jiangsu Univ, Affiliated Hosp, Zhenjiang, Jiangsu, Peoples R China [6]Tianjin Med Univ Gen Hosp, Tianjin, Peoples R China [7]Tsinghua Univ, Beijing Tsinghua Changgung Hosp, Sch Clin Med, Beijing, Peoples R China [8]Sanofi, Shanghai, Peoples R China [9]Sanofi, Frankfurt, Germany [10]Sanofi, Beijing, Peoples R China [11]Sanofi, Bridgewater, NJ USA [12]Sanofi, Paris, France
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关键词: basal insulin GLP-1 analogue glycaemic control hypoglycaemia iGlarLixi type 2 diabetes

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Aims To compare the efficacy and safety of iGlarLixi with insulin glargine 100 units/mL (iGlar) and lixisenatide (Lixi), in Asian Pacific people with suboptimally controlled type 2 diabetes (T2D) on metformin with or without a second oral antihyperglycaemic drug (OAD). Materials and Methods LixiLan-O-AP (NCT03798054) was a 24-week multicentre study in adults (n = 878, mean age 56.0 years, mean body mass index 26.0 kg/m(2)) with glycated haemoglobin (HbA1c) levels >= 53 mmol/mol (7%) and <= 97 mmol/mol (11%) on OAD(s), randomized (2:2:1) to open-label once-daily iGlarLixi, iGlar or Lixi while on continued metformin +/- sodium-glucose cotransporter-2 inhibitors. The primary efficacy endpoint was change in HbA1c. Results After 24 weeks, greater reductions in HbA1c from baseline (67 mmol/mol; 8.3%) were seen with iGlarLixi (-21 mmol/mol; -1.9%) compared with iGlar (-16 mmol/mol; -1.4%; P < 0.0001) and Lixi (-10 mmol/mol; -0.9%; P < 0.0001). Greater proportions of participants achieved HbA1c <53 mmol/mol (<7%) with iGlarLixi versus iGlar or Lixi (79%, 60% and 30%, respectively), overall and as composite endpoints including weight and hypoglycaemia. iGlarLixi improved 2-hour postprandial glucose versus iGlar and Lixi and mitigated the weight gain seen with iGlar (least squares mean difference -1.1 kg; P < 0.0001). Documented <= 3.9 mmol/L (<= 70 mg/dL) hypoglycaemia was similar between iGlarLixi and iGlar (both 3.38 events per participant-year). The incidence rates of nausea and vomiting were lower with iGlarLixi (14% and 6%) than Lixi (21% and 11%). Conclusions iGlarLixi achieved significant HbA1c reductions, to near-normoglycaemic levels, compared with iGlar or Lixi, with no meaningful additional risk of hypoglycaemia and mitigated body weight gain versus iGlar, with fewer gastrointestinal adverse events versus Lixi. iGlarLixi with specifically adapted ratios may provide an efficacious and well-tolerated treatment option for Asian Pacific people with T2D.

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出版当年[2021]版:
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢
最新[2025]版:
大类 | 2 区 医学
小类 | 2 区 内分泌学与代谢
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出版当年[2020]版:
Q1 ENDOCRINOLOGY & METABOLISM
最新[2023]版:
Q1 ENDOCRINOLOGY & METABOLISM

影响因子: 最新[2023版] 最新五年平均[2021-2025] 出版当年[2020版] 出版当年五年平均[2016-2020] 出版前一年[2019版] 出版后一年[2021版]

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第一作者单位: [1]China Japan Friendship Hosp, 2 Yinghuayuan E St, Beijing 100029, Peoples R China [*1]China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang, Beijing 100029, China.
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通讯机构: [1]China Japan Friendship Hosp, 2 Yinghuayuan E St, Beijing 100029, Peoples R China [*1]China-Japan Friendship Hospital, 2 Yinghuayuan E St, Chaoyang, Beijing 100029, China.
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