A recent Journal of Clinical Medicine study investigated the effectiveness of oral semaglutide in patients with type 2 diabetes (T2D).
Study: Oral semaglutide in routine clinical practice: characteristics of type 2 diabetes patients initiating the drug and changes in clinical parameters after 24 weeks of treatment. Image credit: Andrei_R / Shutterstock.com
Indications for semaglutide
Semaglutide is the first oral antidiabetic drug for type 2 diabetes and a unique glucagon-like peptide-1 receptor agonist (GLP-1RA) that can control glycemic index and reduce body weight (BW). In addition to its efficacy, the safety profile of semaglutide has been confirmed in multiple clinical trials.
The PIONEER programme was conducted to determine the effectiveness of oral semaglutide in patients at different stages of diabetes. Depending on the stage of diabetes, patients received a single dose or multiple doses of the oral hypoglycemic agent. Based on the findings of the PIONEER programme, the US Food and Drug Administration (FDA) endorsed the safety and effectiveness of oral semaglutide in 2019, followed by approval by the European Medicines Agency (EMA) in 2020.
According to US and European type 2 diabetes management guidelines, oral semaglutide has beneficial effects on the cardiovascular system and is recommended regardless of glycated hemoglobin (HbA1c) levels, especially in type 2 diabetes patients at high or very high risk of cardiovascular disease (CVD).
Although the results of the PIONEER study are promising, further studies with larger cohorts are needed to validate the efficacy of oral semaglutide in reducing CVD risk, and physicians' willingness to use the agent in routine clinical practice needs to be assessed.
About the Research
The present retrospective study was carried out in two Italian university diabetes centers. Data were obtained from an electronic medical record system software created by an Italian diabetes outpatient clinic to manage patients' medical histories.
The platform collected information on diabetic patients such as weight, HbA1c levels, waist circumference (WC), serum creatinine, blood glucose levels, blood pressure, lipid profile, aspartate aminotransferase (AST), estimated glomerular filtration rate (eGFR), and other laboratory tests. The system also provided data on concomitant medications for selected patients.
Patients were prescribed oral semaglutide during outpatient care. Patients were initially treated with a low dose of 3 mg, which was then increased to 7 mg, and eventually up to 14 mg in some patients to further improve their glycemic index. These patients were monitored for up to 6 months after initiating treatment.
research result
In a routine clinical setting, patients receiving initial oral semaglutide treatment showed suboptimal metabolic control and short diabetes duration. However, after 6 months of treatment, significant clinical improvement in HbA1c levels and weight loss were achieved. These improvements were mainly seen in patients with recently diagnosed diabetes, demonstrating the efficacy of oral semaglutide in the early stages of the disease.
To evaluate the efficacy of oral semaglutide, a total of 192 patients with type 2 diabetes were recruited between September 2021 and December 2022. All participants were white, with a mean age of 67 years.
Approximately 44% of the cohort were women. Study participants had been diagnosed with diabetes for an average of nine years. Mean fasting plasma glucose and HbA1c levels were 146 mg/dL and 7.9%, respectively.
Prior to receiving oral semaglutide treatment, study participants were receiving treatment with a sodium glucose cotransporter-2 inhibitor (SGLT2i), basal or rapid-acting insulin, GLP-1RA, pioglitazone, metformin, DPP4i, or sulfonylurea for the treatment of type 2 diabetes. During the study, at 6 months of oral semaglutide treatment, most patients received 7 mg of semaglutide, but only 2% received the 14 mg dose.
Compared to previous studies, this study did not find significant differences in HbA1c reduction between men and women. All participants experienced similar weight loss, indicating that oral semaglutide is effective in reducing weight regardless of baseline weight.
The metabolic benefits of this treatment were confirmed by significant improvements in lipid profile and WC after 6 months of oral semaglutide therapy. Blood pressure and microalbuminuria levels also improved significantly with semaglutide treatment. Taken together, oral semaglutide plays a role in reducing obesity, improving metabolic health and lowering the glycemic index, with an overall positive effect on CVD.
Conclusion
The current study demonstrated that oral semaglutide could maintain glycemic index and reduce body weight. The treatment also improved cardiovascular risk parameters, including lipid profile, blood pressure levels and metabolic health.
The clinical relevance of oral semaglutide therapy was observed even at doses as low as 7 mg, particularly in patients with recently diagnosed diabetes. Importantly, patients tolerated doses as high as 14 mg oral semaglutide.
Journal References:
Baldassarre, MPA., Di Dalmazi, G., Coluzzi, S., et al. (2024) Oral semaglutide in routine clinical practice: characteristics of patients with type 2 diabetes initiating this drug and changes in clinical parameters after 24 weeks of treatment. Journal of Clinical Medicine 13(11); 3054. doi:10/10.3390/jcm13113054
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