Real world effectiveness of fixed ratio combination of glargine 100 U/ml and lixisenatide therapy in outpatients with type 2 diabetes depending on body mass index and dose timing: post hoc analysis of the SOLO study

• Mikhail B. Antsiferov
• Nikolay A. Demidov
• Mariya A. Balberova
• Tatyana I. Safronova
• Olga A. Mishra

Abstract

The SOLO study is a retrospective cohort study conducted in Moscow, Russia, using medical records of adults with type 2 diabetes mellitus (T2DM) who started treatment with a fixed ratio combination of insulin glargine 100 U/mL and lixisenatide (iGlarLixi) in the period from November 2018 to July 2020. The aim of the SOLO study was to evaluate the effectiveness of iGlarLixi therapy in a real outpatient practice. This article describes results of post hoc analysis of the SOLO study.

Aim. To evaluate the impact of the time of drug administration and baseline body mass index (BMI) on the effectiveness of iGlarLixi, a fixed-ratio combination of glargine 100 U/ml and lixisenatide, in adults with type 2 diabetes mellitus (T2DM) in real clinical practice, the SOLO study.

Material and methods. Available medical records of adults (≥18 years) with T2DM and glycated hemoglobin (HbA1c) ≥7% for ≥180 days before and during 150–210 days after start of treatment with iGlarLixi were eligible. Post hoc analysis of main outcomes (HbA1c and body weight reduction, risk of hypoglycemia) was conducted in subgroups of adults with different iGlarLixi administration time (before breakfast, lunch or dinner) and in subgroups with different baseline BMI (25– <30, 30– <35, ≥35 kg/m²).

Results. The use of iGlarLixi in all analyzed subgroups of patients (with different baseline BMI and dose timing) led to a significant improvement in glycemic control at 6 and 12 months – ​a decrease of FPG and HbA1c levels. In the group of patients who used of iGlarLixi before breakfast (n=244), the HbA1c level decreased from 9.2±1.2% at baseline to 7.8±0.9% after 6 months and 7.4±0.6% after 12 months. In the group of patients with use of iGlarLixi before lunch (n=52), the HbA1c level decreased from 8.9±0.9 at baseline to 7.7±0.7 and 7.4±0.7% after 6 and 12 months, respectively; while using the drug before dinner (n=87) – ​from 9.0±0.9 to 7.8±0.7% after 6 months and up to 7.4±0.6% after 12 months (p<0.001). In the group of patients with BMI 25 and <30 kg/m² (n=45), the level of HbA1c decreased from 9.5±1.4% to 7.7±0.6% after 6 months, to 7.4±0.6% after 12 months. In the group with BMI 30– <35 kg/m² (n=132) from 9.0±1.0 to 7.7±0.7% after 6 months and to 7.3±0.6% after 12 months; in patients with BMI ≥35 kg/m² (n=196) – ​from 9.1±1.0 to 7.8±0.8% after 6 months and to 7.4±0.7% after 12 months (p<0.001). In all groups of patients the weight decreased significantly. Treatment with iGlarLixi was associated with a low risk of hypoglycemia, including severe hypoglycemia.

Conclusion. In real clinical practice, the time of iGlarLixi administration and baseline BMI did not have an impact on HbA1c reduction. Most significant reduction in body weight was observed in patients who administrated iGlarLixi before breakfast, and in patients with higher baseline BMI values.

Keywords:fixed ratio combination of insulin glargine 100 U/mL and lixisenatide; diabetes mellitus type 2; glargine; lixisenatide; iGlarLixi

References

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