Diabetes, obesity & metabolism · 2026
Impact of Time of Injection on the Efficacy and Safety of iGlarLixi Versus IDegAsp in Chinese People With Type 2 Diabetes: Exploratory Analysis of the Soli-D Study.
Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Li Xin, Wang Juan, Liu Tong, Alvarez Agustina, Lauand Felipe, Melas-Melt Lydie, Kang Lei, Du Qin, Liu Ming
Аннотация
AIMS: To compare the efficacy and safety of the fixed-ratio combination of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with premixed insulin degludec plus insulin aspart (IDegAsp) according to the injection time of IDegAsp.
MATERIALS AND METHODS: The 24-week, multicentre, randomised, open-label Soli-D study enrolled Chinese adults with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drugs (OADs). This exploratory analysis evaluated glycaemic efficacy, body weight, basal insulin daily dose and hypoglycaemia outcomes with once-daily iGlarLixi (injected before breakfast) versus IDegAsp (injected before breakfast, lunch or dinner).
RESULTS: Of 582 participants, 291 received iGlarLixi, with injections self-administered before breakfast, and 291 received IDegAsp, with injections self-administered before breakfast (n = 139), lunch (n = 54) or dinner (n = 98). Glycated haemoglobin (HbA1c) reductions from baseline to Week 24 were greater with iGlarLixi than IDegAsp injected before lunch (least squares mean difference -0.24% [-2.3 mmol/mol]) or dinner (-0.29% [-3.2 mmol/mol]), and slightly greater than IDegAsp injected before breakfast (-0.12% [-1.3 mmol/mol]). Average 2-h postprandial glucose (2-h PPG) reductions were also greater with iGlarLixi than IDegAsp, regardless of injection time. iGlarLixi provided additional benefits, including reduced body weight, lower total insulin doses and less hypoglycaemia risk compared with IDegAsp in all injection-time subgroups.
CONCLUSIONS: Once-daily iGlarLixi, injected before breakfast, was associated with improved HbA1c control and greater average 2-h PPG reductions compared with IDegAsp, regardless of injection time, in Chinese adults with T2D suboptimally controlled with OADs.
MATERIALS AND METHODS: The 24-week, multicentre, randomised, open-label Soli-D study enrolled Chinese adults with type 2 diabetes (T2D) suboptimally controlled with oral antidiabetic drugs (OADs). This exploratory analysis evaluated glycaemic efficacy, body weight, basal insulin daily dose and hypoglycaemia outcomes with once-daily iGlarLixi (injected before breakfast) versus IDegAsp (injected before breakfast, lunch or dinner).
RESULTS: Of 582 participants, 291 received iGlarLixi, with injections self-administered before breakfast, and 291 received IDegAsp, with injections self-administered before breakfast (n = 139), lunch (n = 54) or dinner (n = 98). Glycated haemoglobin (HbA1c) reductions from baseline to Week 24 were greater with iGlarLixi than IDegAsp injected before lunch (least squares mean difference -0.24% [-2.3 mmol/mol]) or dinner (-0.29% [-3.2 mmol/mol]), and slightly greater than IDegAsp injected before breakfast (-0.12% [-1.3 mmol/mol]). Average 2-h postprandial glucose (2-h PPG) reductions were also greater with iGlarLixi than IDegAsp, regardless of injection time. iGlarLixi provided additional benefits, including reduced body weight, lower total insulin doses and less hypoglycaemia risk compared with IDegAsp in all injection-time subgroups.
CONCLUSIONS: Once-daily iGlarLixi, injected before breakfast, was associated with improved HbA1c control and greater average 2-h PPG reductions compared with IDegAsp, regardless of injection time, in Chinese adults with T2D suboptimally controlled with OADs.