Efficacy and Safety of iGlarLixi Versus IDegAsp by Baseline Age, Disease Duration and HbA1c in Chinese People With Type 2 Diabetes: Post Hoc Analyses of the Soli-D Study.
iGlarLixi may offer better glycaemic control with lower insulin doses and hypoglycaemia risk in Chinese adults with Type 2 diabetes compared to IDegAsp.
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. It found greater HbA1c reductions and lower hypoglycaemia rates with iGlarLixi, regardless of age, disease duration, or baseline HbA1c. The study involved 582 participants randomized equally between the two treatments.
Abstract
<h4>Aims</h4>To compare the efficacy and safety of insulin glargine 100 U/mL plus lixisenatide (iGlarLixi) with insulin degludec plus insulin aspart (IDegAsp) by baseline age, Type 2 diabetes (T2D) duration and glycated haemoglobin (HbA1c) in the Soli-D study.<h4>Materials and methods</h4>In Soli-D, Chinese adults with T2D suboptimally controlled on oral antidiabetic drugs (OADs) were randomized to iGlarLixi or IDegAsp for 24 weeks. These post hoc analyses evaluated glycaemic efficacy, insulin dose, body weight and hypoglycaemia outcomes in subgroups defined by baseline age (< 65, ≥ 65 years), T2D duration (< 10, ≥ 10 years) and HbA1c (≥ 7% to ≤ 8% [≥ 53 to ≤ 64 mmol/mol], > 8% to ≤ 9% [> 64 to ≤ 75 mmol/mol], > 9% [> 75 mmol/mol]).<h4>Results</h4>Among 582 participants (iGlarLixi n = 291; IDegAsp n = 291), baseline age was < 65 years in 442 and ≥ 65 years in 140; T2D duration was < 10 years in 366 and ≥ 10 years in 216; and HbA1c was ≥ 7% to ≤ 8% in 205, > 8% to ≤ 9% in 209 and > 9% in 168. At Week 24, HbA1c reductions were greater with iGlarLixi versus IDegAsp, with no treatment-by-subgroup interactions for baseline age, T2D duration or HbA1c. Change in other glycaemic outcomes, insulin dose and body weight generally showed no interaction across subgroups. Total insulin daily doses during treatment and hypoglycaemia event rates were consistently lower with iGlarLixi versus IDegAsp in all subgroups.<h4>Conclusions</h4>iGlarLixi provides improved glycaemic control at lower insulin doses with reduced risk of hypoglycaemia in Chinese adults with suboptimally controlled T2D on OADs, regardless of baseline age, disease duration or HbA1c.
Background
This study addresses the need for effective glycaemic control in Chinese adults with Type 2 diabetes inadequately managed with oral antidiabetic drugs. Previous research has explored the efficacy of various insulin combinations, but specific data on iGlarLixi versus IDegAsp in this population was lacking. Understanding these differences is crucial for optimizing diabetes management strategies.
Methods
The Soli-D study was a randomized trial involving 582 Chinese adults with Type 2 diabetes inadequately controlled on oral antidiabetic drugs. Participants were randomized to receive either iGlarLixi or IDegAsp for 24 weeks. Post hoc analyses were conducted to evaluate glycaemic efficacy, insulin dose, body weight, and hypoglycaemia outcomes across subgroups defined by baseline age, disease duration, and HbA1c levels.
Results
At Week 24, iGlarLixi showed greater reductions in HbA1c compared to IDegAsp, with no significant treatment-by-subgroup interactions for baseline age, T2D duration, or HbA1c. Insulin doses and hypoglycaemia event rates were consistently lower with iGlarLixi across all subgroups. These findings suggest a more favorable safety and efficacy profile for iGlarLixi.
Interpretation
The findings align with prior literature suggesting the efficacy of iGlarLixi in improving glycaemic control. However, the clinical significance of the effect size should be interpreted cautiously due to the post hoc nature of the analysis. The study's focus on a Chinese population may limit its applicability to broader populations. Despite these limitations, the results support the potential use of iGlarLixi for better glycaemic management in similar patient groups.
Key findings
- 582 participants (iGlarLixi n=291; IDegAsp n=291).
- Baseline age <65 years in 442 participants, ≥65 years in 140.
- T2D duration <10 years in 366 participants, ≥10 years in 216.
- HbA1c reductions greater with iGlarLixi vs IDegAsp at Week 24.
- Lower insulin doses and hypoglycaemia rates with iGlarLixi.
Limitations
- Post hoc analysis
- Limited to Chinese population
- 24-week duration
- Subgroup analysis