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.
iGlarLixi may provide better glycemic control and safety than IDegAsp in Chinese adults with type 2 diabetes, but findings should be interpreted with caution due to study limitations.
Where it sits
this study against the rest of the lixisenatide corpusSummary and findings
The study compared the efficacy and safety of iGlarLixi versus IDegAsp in Chinese adults with type 2 diabetes over 24 weeks. iGlarLixi showed greater reductions in HbA1c and 2-hour postprandial glucose compared to IDegAsp, regardless of injection timing. Additional benefits included reduced body weight, lower insulin doses, and less hypoglycemia risk with iGlarLixi.
Abstract
<h4>Aims</h4>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.<h4>Materials and methods</h4>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).<h4>Results</h4>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.<h4>Conclusions</h4>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.
Background
This study addresses the efficacy and safety of different insulin regimens in managing type 2 diabetes, specifically comparing a fixed-ratio combination of insulin glargine and lixisenatide with a premixed insulin regimen. Previous research has highlighted the importance of optimizing insulin therapy for glycemic control in diabetes management. This study is significant as it explores the impact of injection timing on treatment outcomes, which could influence clinical practice.
Methods
The Soli-D study was a 24-week, multicenter, randomized, open-label trial involving Chinese adults with type 2 diabetes inadequately controlled with oral antidiabetic drugs. Participants were randomized to receive either once-daily iGlarLixi before breakfast or IDegAsp before breakfast, lunch, or dinner. The primary outcomes included changes in HbA1c and 2-hour postprandial glucose levels, with secondary outcomes assessing body weight, insulin dose, and hypoglycemia incidence.
Results
The study found that iGlarLixi led to greater reductions in HbA1c compared to IDegAsp, particularly when IDegAsp was injected before lunch (-0.24%) or dinner (-0.29%). Additionally, iGlarLixi resulted in greater reductions in 2-hour postprandial glucose levels regardless of IDegAsp injection timing. Participants on iGlarLixi also experienced reduced body weight, required lower total insulin doses, and had a lower risk of hypoglycemia across all injection-time subgroups.
Interpretation
The findings suggest that iGlarLixi may offer superior glycemic control and safety benefits over IDegAsp in this population, particularly in terms of HbA1c and postprandial glucose reductions. However, the open-label design and focus on a Chinese cohort limit the generalizability of results. While statistically significant, the clinical significance of the observed HbA1c differences should be considered in the context of individual patient needs and treatment goals.
Key findings
- 582 participants, n=291 for iGlarLixi, n=291 for IDegAsp.
- HbA1c reduction greater with iGlarLixi vs IDegAsp before lunch (-0.24%) or dinner (-0.29%).
- 2-h PPG reductions greater with iGlarLixi regardless of injection time.
- iGlarLixi associated with reduced body weight and lower insulin doses.
- Less hypoglycemia risk with iGlarLixi compared to IDegAsp.
Limitations
- open-label design
- limited to Chinese population
- exploratory analysis
- short 24-week duration