Browsing by Subject "Fixed‐ratio combination"

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    Effect of iGlarLixi on continuous glucose monitoring—measured time in range in insulin‐naive adults with suboptimally controlled type 2 diabetes
    (Wiley, 2025) Frías, Juan P.; Ratzki‐Leewing, Alexandria; Dex, Terry; Meneghini, Luigi; Rodrigues, Amélie; Shah, Viral N.; Medicine, School of Medicine
    Aims: People with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) ≥9% may benefit from fixed-ratio combination therapies such as iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL). Use of continuous glucose monitoring (CGM) is recommended, but data are lacking to assess the impact of iGlarLixi in individuals with HbA1c ≥9%. Materials and methods: Soli-CGM (NCT05114590) was a 16-week, multicentre, open-label study evaluating the efficacy of once-daily iGlarLixi using blinded CGM-based metrics in insulin-naive adults with HbA1c ≥9%-13% who were receiving ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The primary outcome was the change from baseline to week 16 in percent time in range (TIR; 70-180 mg/dL). Secondary outcomes included change in mean daily blood glucose (BG), maximum postprandial glucose 4 h post-breakfast (PPG-4 h), and time above range (TAR; >180 mg/dL). On-treatment hypoglycaemia was assessed. Results: The study enrolled 124 participants (mean age, 55.6 years; HbA1c, 10.2%). Sixteen weeks of treatment with iGlarLixi improved TIR (+26.2%), mean BG (-52.5 mg/dL), maximum PPG-4 h (-73.7 mg/dL), and TAR (-28.7%); all p < 0.001. Rates of American Diabetes Association level 1 (BG <70 but ≥54 mg/dL) and level 2 (BG <54 mg/dL) hypoglycaemia were reported as 1.4 and 0.6 events per person-year, respectively. No level 3 events (requiring assistance) were reported. Conclusions: In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RAs, 16 weeks of treatment with iGlarLixi significantly improved TIR and reduced TAR without severe hypoglycaemia.
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    Treatment satisfaction and time in range after 16 weeks of treatment with iGlarLixi in insulin-naive adults with suboptimally controlled type 2 diabetes
    (Wiley, 2025) Shah, Viral N.; Dex, Terry; Meneghini, Luigi; Rodrigues, Amélie; Polonsky, William H.; Medicine, School of Medicine
    Aims: In Soli-CGM, treatment with iGlarLixi (insulin glargine 100 U/mL and lixisenatide 33 μg/mL) in insulin-naive adults with suboptimally controlled type 2 diabetes (T2D; haemoglobin A1c 9%-13% on ≥2 oral antihyperglycaemic agents (OADs) ± glucagon-like peptide-1 receptor agonist (GLP-1 RA) therapy) increased time in range (TIR; primary endpoint) from 26.4% at baseline to 52.7% at Week 16. This exploratory analysis examined the impact of treatment with iGlarLixi on patient-reported treatment satisfaction. Materials and methods: Soli-CGM was a single-arm, 16-week, multicentre, interventional, open-label, phase 4 study using blinded continuous glucose monitoring (CGM; FreeStyle Libre Pro) to assess glycaemic metrics (N = 124). CGM data were collected for a 2-week period before initiation of iGlarLixi, and after treatment with iGlarLixi (Weeks 14-16). Treatment satisfaction was assessed using the Diabetes Medication Treatment Satisfaction Tool (DM-SAT, which comprises four domains: well-being, medical control, lifestyle and convenience), at baseline and end-of-treatment. Association of TIR and overall satisfaction (sum of all items) was also assessed. Results: Overall, 118 (95.9%) and 107 (87.0%) participants completed the DM-SAT at baseline and Week 16, respectively. Mean overall score increased by 0.18, from 0.59 (baseline) to 0.78 (Week 16). A trend in improvement in score was observed in all domains. Improvement in TIR had a positive, but weak, trend of association with improvement in overall treatment satisfaction (mean r = 0.14). Conclusions: In people with T2D suboptimally controlled on ≥2 OADs ± GLP-1 RA, 16 weeks' treatment with iGlarLixi resulted in a trend of improvement in treatment satisfaction.