Early Insight Into the Retrospective Data of a Case Series on Type 2 Diabetes Mellitus on Alternate-Day Dosing of Oral Semaglutide: Utopia or Reality?

Abstract

IntroductionOral semaglutide, with a long half-life of seven days, is the first oral-based peptide drug and is used as an antidiabetic for the reduction of glycosylated hemoglobin (HbA1c). Oral semaglutide, like other glucagonlike peptide-1 receptor agonists (GLP1RAs), is costly and has gastrointestinal (GI) side effects, especially with a 14 mg dose. In the real world, some type 2 diabetes mellitus (T2DM) patients on 14 mg oral dose adopt an alternate-day strategy to minimize unwanted GI symptoms. In this study, we analyzed the ambulatory glucose profile (AGP) data of patients with T2DM who were on 14 mg alternate-day oral semaglutide therapy. MethodsThis retrospective observational study evaluated the AGP data of 10 patients on alternate-day dosing of 14 mg oral semaglutide. The AGP data over a period of 14 days on a single group of patients were analyzed without any control group or randomization and are presented as a case series. AGP monitoring, using Freestyle Libre Pro (Abbott, Illinois, United States), is a standard operating procedure of the endocrinology department for all T2DM patients who were put on oral semaglutide therapy. The AGP data of the glycemic parameters time-in-range (TIR), time-above-range (TAR), and time-below-range (TBR), were compared between the days when oral semaglutide was consumed (days-on-drug) versus the days when oral semaglutide was not consumed (days-off-drug). The statistical analysis was done with Statistical Package for Social Sciences (SPSS) version 21.0 (IBM Corp., Armonk, NY). ResultsWe applied the Shapiro-Wilk test (sample size <50) for normality testing; the TIR values of days-on-drug and days-off-drug showed high p values (p =0.285 and 0.109), respectively. This indicated that TIR values dayson-drug and days-off-drug were normally distributed. Although, the distribution of TAR and TBR values days-on-drug and days-off-drug, were not normal as they had small p values (p< 0.05). Hence, further analysis of the paired set of data was done using the Wilcoxon signed-rank test. It revealed no difference in TIR, TAR, and TBR between the two groups (days-on-drug and days-off-drug). ConclusionThroughout the period of observation, the glycemic metrics (TIR, TAR, and TBR) remained steady with a 14 mg alternate-day oral semaglutide regimen.

Glycemic Control and the Weight Benefit of a Daily 7 mg Dose of Oral Semaglutide Versus an Alternate-Day 14 mg Dose of Oral Semaglutide From an Ambulatory Glucose Monitoring Data: A Retrospective Cohort Study From Eastern India

“…This is of paramount importance in the present context: as the primary reason for non-adherence to the prescribed drug regimen, especially in the case of chronic disorders, the cost of medication is increasing [16][17][18][19]. In our previous study on the alternate-day 14 mg dose of oral semaglutide, the average values of TIR and TBR between the days-on-drug versus the days-off-drug had no statistically significant difference [12].…”

“…Some of the patients by their ingenuity devised a self-made protocol of an alternate-day 14 mg dose of oral semaglutide to alleviate the GI symptoms and to reduce the cost (presumed but not directly disclosed by any patient). The self-monitoring of the blood glucose log of these patients looked identical on days of oral semaglutide usage (days-on-drug) versus the days of voluntary drug abstinence (days-off-drug) [12]. This finding led us to compare their ambulatory glucose profile (AGP) data during the daily 7 mg dose of oral semaglutide and AGP data during the alternate-day 14 mg dose of the same patient.…”

GLP-1 analogs: a comparison of new anti diabetic medications - presenting benefits and risks

“…Administering the drug orally with other medications reduces its absorption. Nausea, diarrhea, and complications from diabetic retinopathy are among the side effects [89]. In the case of oral administration, conditions such as gastroesophageal reflux disease, gallstones, increased lipase and amylase activity may occur.…”