A Multicentre, Prospective, Non-Interventional Single-Arm Study Investigating the Impact of Once-Daily Oral Semaglutide in a Real-World Adult Population With Type 2 Diabetes in Mexico
Abstract
Background: To investigate the oral semaglutide use among Mexican adults with type 2 diabetes.
Methods: PIONEER REAL was a multinational, open-label study evaluating oral semaglutide in patients without prior injectable glucose-lowering treatment. This analysis focuses on data from Mexico.
Results: Of 177 patients, 139 (78.5%) completed the study and 111 (62.7%) remained on treatment at the end. The mean (SD) age was 54.0 (10.96) years, 57.6% were women, 59.3% had obesity, and 44.6% had a medical history of cardiovascular disease. The average T2D duration was 5.7 years (SD 6.45), with mean HbA1c at 8.1% (SD 1.85). At week 38, mean HbA1c had decreased to 6.8% (estimated mean [SE] change in HbA1c, -1.3% [0.11]; p < 0.0001), and body weight had decreased from 87.8 kg (19.34) to 85.3 kg (estimated mean [SE] change in body weight, -4.3 kg [0.56]; p < 0.0001), as had waist circumference (estimated mean [SE] change, -3.7 cm [0.54]; p < 0.0001). Additionally, satisfaction with treatment increased over time. Only 6.2% of patients had adverse events leading to withdrawal of semaglutide.
Conclusions: According to this real-world study, starting oral semaglutide treatment in Mexico is associated with notable decreases in both HbA1c levels and body weight among patients with type 2 diabetes. Satisfaction with treatment also improved significantly. Moreover, the safety profile is consistent with that of previous studies.
Trial registration: ClinicalTrials.gov registration NCT04601753.
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 177 participants or records.
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