دورية أكاديمية
Findings for iGlarLixi versus BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics.
| العنوان: | Findings for iGlarLixi versus BIAsp 30 confirmed in groups of people with type 2 diabetes with different biomedical characteristics. |
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| المؤلفون: | Home PD; Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK., McCrimmon RJ; Division of Systems Medicine, School of Medicine, University of Dundee, Dundee, UK., Rosenstock J; Velocity Clinical Research at Medical City, Dallas, Texas, USA., Blüher M; Department of Medicine, University of Leipzig, Leipzig, Germany., Pegelow K; Sanofi, Berlin, Germany., Melas-Melt L; IVIDATA Life Sciences, Levallois-Perret, France., Djaballah K; Sanofi, Paris, France., Giorgino F; Department of Emergency and Organ Transplantation, Section of Internal Medicine, Endocrinology, Andrology and Metabolic Diseases, University of Bari Aldo Moro, Bari, Italy. |
| مؤلفون مشاركون: | SoliMix trial investigators |
| المصدر: | Diabetes, obesity & metabolism [Diabetes Obes Metab] 2023 Mar; Vol. 25 (3), pp. 656-663. Date of Electronic Publication: 2022 Nov 23. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Wiley-Blackwell Country of Publication: England NLM ID: 100883645 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1463-1326 (Electronic) Linking ISSN: 14628902 NLM ISO Abbreviation: Diabetes Obes Metab Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Oxford : Wiley-Blackwell, c1999- |
| مواضيع طبية MeSH: | Diabetes Mellitus, Type 2*/drug therapy , Hypoglycemia*/chemically induced , Hypoglycemia*/prevention & control , Hypoglycemia*/drug therapy, Humans ; Insulin Aspart/therapeutic use ; Hypoglycemic Agents/adverse effects ; Glycated Hemoglobin ; Blood Glucose ; Insulin Glargine/therapeutic use ; Drug Combinations |
| مستخلص: | Aim: To report prespecified and post hoc analyses of the SoliMix dataset exploring the impact of baseline participant characteristics on the original SoliMix study outcomes, to enable informed treatment choices for people with different biomedical characteristics. Methods: SoliMix (EudraCT 2017-003370-13) compared once-daily iGlarLixi (a fixed-ratio combination of insulin glargine 100 U/mL and the glucagon-like peptide-1 receptor agonist lixisenatide) with twice-daily BIAsp 30 (30% insulin aspart and 70% insulin aspart protamine). In this analysis, the original primary outcomes of noninferiority of iGlarLixi versus BIAsp 30 in terms of glycated haemoglobin (HbA1c) change and superiority in terms of body weight change, together with change in basal insulin dose and hypoglycaemia outcomes, were investigated by baseline age, duration of diabetes, insulin dose, HbA1c level, body mass index (BMI), and renal function. Results: No evidence of difference in comparative treatment effect was detected across baseline age, duration of diabetes, insulin dose, HbA1c level, BMI and renal function subgroups for any endpoint (all heterogeneity P > 0.05), except American Diabetes Association Level 2 hypoglycaemia event rate when stratified by insulin dose (P = 0.011), which may be a chance difference given multiple testing and the small numbers of Level 2 events. Conclusions: Treatment effects of iGlarLixi were consistent irrespective of baseline HbA1c, insulin dose, BMI, age, duration of diabetes and renal function, supporting the use of iGlarLixi as an efficacious and well-tolerated treatment option in people with type 2 diabetes with a wide range of biomedical characteristics. (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.) |
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| فهرسة مساهمة: | Keywords: GLP-1 analogue; basal insulin; glycaemic control; hypoglycaemia; iGlarLixi; insulin therapy; randomized trial; type 2 diabetes |
| المشرفين على المادة: | 0 (insulin aspart, insulin aspart protamine drug combination 30:70) D933668QVX (Insulin Aspart) 0 (Hypoglycemic Agents) 0 (Glycated Hemoglobin) 0 (Blood Glucose) 2ZM8CX04RZ (Insulin Glargine) 0 (Drug Combinations) |
| تواريخ الأحداث: | Date Created: 20221030 Date Completed: 20230203 Latest Revision: 20230415 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC10099981 |
| DOI: | 10.1111/dom.14907 |
| PMID: | 36309941 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1463-1326 |
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| DOI: | 10.1111/dom.14907 |