Insulin glargine-lixisenatide Significantly Improves Blood Sugar Control in Insulin-Naive Adults with Type 2 Diabetes: Study

The researchers note that fixed-ratio combination therapies like iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL) may benefit individuals with type 2 diabetes and glycated hemoglobin (HbA1c) ≥9%. While continuous glucose monitoring (CGM) is recommended, data on iGlarLixi’s impact on this population remains limited.

The Soli-CGM study was designed to evaluate the effects of iGlarLixi over 16 weeks in insulin-naive adults with suboptimally controlled T2D on at least two oral antihyperglycemic agents, with or without GLP-1 RAs, using blinded CGM-derived glucose metrics. A post hoc analysis by Juan P. Frías, Biomea Fusion, Redwood City, CA, USA, and colleagues examined outcomes based on concomitant sulfonylurea (SU) therapy.

The Soli-CGM study was a 16-week, multicenter, open-label trial investigating the efficacy of once-daily iGlarLixi in insulin-naive adults with HbA1c levels between 9% and 13% who were receiving at least two OADs, with or without GLP-1 receptor agonists. Using blinded CGM-based metrics, the study primarily assessed changes in time-in-range (TIR; 70–180 mg/dL) from baseline to week 16. Secondary outcomes included changes in mean daily blood glucose (BG), maximum postprandial glucose 4 hours after breakfast (PPG-4h), and time above range (TAR; >180 mg/dL), with on-treatment hypoglycemia also evaluated.

Key Findings:

• The study included 124 participants with a mean age of 55.6 years and an average HbA1c of 10.2%.
• After 16 weeks of iGlarLixi treatment, time-in-range (TIR) improved by 26.2%, mean blood glucose (BG) decreased by 52.5 mg/dL, maximum postprandial glucose 4 hours after breakfast (PPG-4h) reduced by 73.7 mg/dL, and time above range (TAR) decreased by 28.7%.
• Hypoglycemia rates were 1.4 events per person-year for level 1 (BG <70 but ≥54 mg/dL) and 0.6 events per person-year for level 2 (BG <54 mg/dL).
• There were no level 3 hypoglycemic events (requiring assistance).

The authors demonstrated that in individuals with type 2 diabetes suboptimally controlled on at least two oral antihyperglycemic agents, with or without GLP-1 receptor agonists, 16 weeks of iGlarLixi treatment significantly improved time-in-range and reduced time-above-range without severe hypoglycemia.

"Our findings complement existing data, highlighting the benefits of iGlarLixi in individuals with very high HbA1c despite multiple therapies. By incorporating continuous glucose monitoring metrics, the study provides a broader understanding of iGlarLixi’s efficacy beyond traditional HbA1c measures," the authors concluded.

Reference:

Frías JP, Ratzki-Leewing A, Dex T, Meneghini L, Rodrigues A, Shah VN. Effect of iGlarLixi on continuous glucose monitoring-measured time in range in insulin-naive adults with suboptimally controlled type 2 diabetes. Diabetes Obes Metab. 2025 Feb 4. doi: 10.1111/dom.16214. Epub ahead of print. PMID: 39905643.