Safety and clinical effectiveness of iGlarLixi in people with type 2 diabetes mellitus in Mexico

Abstract

Aims

To evaluate the safety and effectiveness of iGlarLixi in people with type 2 diabetes mellitus (T2DM) in clinical practice in Mexico.

Materials and Methods

This was a prospective, observational, multicentre study in adults with T2DM who were prescribed iGlarLixi in routine clinical practice in Mexico. The participants were followed for 24 ± 1 months. The primary endpoint included the incidence proportion, incidence rate of adverse drug reactions (ADRs), serious ADRs and the severity of suspected ADRs possibly related to iGlarLixi throughout the study.

Results

The study included 330 participants (mean ± SD age: 57.8 ± 11.9 years, weight: 77.1 ± 17.7 kg, duration of diabetes: 14.1 ± 9.9 years, and female: 55.5%). During the 24-month study, 59 participants (17.9%; 95% confidence interval [CI]: 13.9–22.4) reported 95 ADRs, with a mean of 0.164 events per participant-year. The most commonly reported ADRs were gastrointestinal disorders (11.2%), with nausea being the most frequent (7.3%). HbA1c decreased from 9.5% at baseline to 7.3% at the end of the study. Additionally, 51.7%, 64.6% and 86.3% of participants achieved the glycaemic target of HbA1c < 7%, FPG < 110 mg/dL and PPG < 180 mg/dL, respectively, at the end of the study. A significant decrease (p < 0.0001) in 7-point self-monitoring plasma or capillary blood glucose was observed from baseline to 3, 6, 12 and 24 months post iGlarLixi initiation.

Conclusions

iGlarLixi demonstrated a consistent safety profile aligned with findings from previous randomised controlled trials. The most common ADRs were gastrointestinal disorders that were generally tolerable. Over 50% of participants treated with iGlarLixi achieved their glycaemic targets.