Effect of iGlarLixi on continuous glucose monitoring—measured time in range in insulin‐naive adults with suboptimally controlled type 2 diabetes

Feb 5, 2025Diabetes, obesity & metabolism

iGlarLixi and daily blood sugar control in insulin-naive adults with poorly controlled type 2 diabetes

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Abstract

Treatment with iGlarLixi resulted in a 26.2% increase in for patients with type 2 diabetes and high HbA1c levels.

Participants experienced a reduction in mean daily blood glucose by 52.5 mg/dL after 16 weeks.
Maximum postprandial glucose levels decreased by 73.7 mg/dL four hours after breakfast.
for blood glucose levels greater than 180 mg/dL decreased by 28.7%.
Rates of level 1 hypoglycaemia were reported at 1.4 events per person-year, and level 2 at 0.6 events per person-year.
No severe hypoglycaemia events, which require assistance, were reported during the study.

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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 (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 (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.

Key numbers

26.2%

Increase in ()

increased from 26.44% at baseline to 52.65% at week 16.

52.5 mg/dL

Decrease in Mean Daily Blood Glucose

Mean daily blood glucose decreased significantly over the treatment period.

1.4

Hypoglycaemia Incidence Rate

Level 1 hypoglycaemia events reported as 1.4 events per person-year.

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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

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