Semaglutide Oral in Indian T2DM Patients (SOLID) Study Baseline Demographics

Oral semaglutide is the first oral glucagon-like peptide-1 receptor agonist for the treatment of type 2 diabetes, and showed significant benefits in glycaemic control and weight reduction versus active comparators in the PIONEER clinical trial programme. Oral semaglutide was launched in India on January 15, 2022. In this prospective study, we present early data (first from Indian subcontinent) on the use of oral semaglutide in clinical practice, from the eight centres across India.

Methods:

Prospective real-world study based on EMR from eight centres across India representative of the country’s diverse population. Baseline demographics, glycemic parameters and self-reported adverse events for all patients who were initiated on Oral semaglutide between 15th January and 28th February 2022 was captured.

Results:

In 197 patients prescribed oral semaglutide, 104 (52.8%) were men, and the mean age (SD) was 49.65 years (13.35). Although prescribing information recommends initiating with dose 3 mg, however only 129 (65.48%) of patients received a prescription only for the initial 3 mg dose. 26% were initiated on 7mg and the rest 8.52% were initiated with 14 mg. The patients who are already on other GLP-1RAs were initiated on oral semaglutide 7 mg. Mean body weight was 90.28 kg (15.22); mean HbA1c was 8.4% (1.8%). The most common self-reported side effects with Oral semaglutide were GI intolerance- nausea and vomiting (22%) which subsided within three weeks. Gi side effects were dose dependent. Lowest with 3mg (5%). With 7mg incidences of nausea and vomiting was 13%. None were initiated with 14 mg unless they were previous GLP1 RA users. Between GLP1 RA users and GLP1 RA naive patients, incidences of GI side effects were considerably lower in those who had been on GLP1 RA (7%) vs Naive 15%. None of the patients required discontinuation of therapy due to GI side effects.

Discussion/Conclusion:

These data indicate early demographic and clinical characteristics of the patients initiated on oral semaglutide from multiple centres in India. The study also intends to look into the glycemic endpoints and the mean-dose required to achieve the changes in bodyweight, BMI and other clinical parameters at 13 weeks and 26 weeks and also adverse events. The study also highlights differences between the real-world practice and global recommendations regarding initiation dose of Rybelsus.