Seino Y, et al. – The physicians conducted this work to evaluate the safety and efficacy of monotherapy with once–weekly subcutaneous (s.c.) semaglutide versus sitagliptin in Japanese subjects with type 2 diabetes (T2D). As per the results, more treatment–emergent adverse events (TEAEs) were reported with semaglutide versus sitagliptin in Japanese subjects with T2D ; nevertheless, the semaglutide safety profile was similar to that of other glucagon–like peptide–1 (GLP–1) receptor agonists. Semaglutide significantly reduced HbA1c and body weight versus sitagliptin.

Methods

• Researchers designed phase 3a randomized, open–label, parallel–group, active–controlled, multicentre trial including adult Japanese subjects with T2D treated with diet and exercise only or oral antidiabetic drug monotherapy (washed–out in run–in period) received once–weekly s.c. semaglutide (0.5 or 1.0 mg) or once–daily oral sitagliptin 100 mg.
• The preliminary outcomes was number of treatment–emergent adverse events (TEAEs) after 30 weeks.

Results

• They randomized a sum of 308 subjects and exposed to treatment, with similar baseline characteristics across groups.
• They noted overall 2.9% of subjects in both the semaglutide 0.5 mg and the sitagliptin group prematurely discontinued treatment, compared with 14.7% in the semaglutide 1.0 mg group.
• The majority of discontinuations in the semaglutide 0.5 and 1.0 mg groups were due to adverse events.
• It was showed that more TEAEs were reported in semaglutide– versus sitagliptin–treated subjects (74.8%, 71.6% and 66.0% in the semaglutide 0.5, 1.0 mg and sitagliptin groups, respectively).
• It was showed that adverse events were mainly mild to moderate.
• The data demonstrated that gastrointestinal adverse events, most frequently reported with semaglutide, diminished in frequency over time.
• It was noted that mean HbA1c (baseline 8.1%) decreased by 1.9% and 2.2% with semaglutide 0.5 and 1.0 mg, respectively, versus 0.7% with sitagliptin (estimated treatment difference versus sitagliptin [ETD] –1.13% [95% confidence interval –1.32; –0.94] and –1.44% [–1.63; –1.24], both p<0.0001).
• The results revealed that body weight (baseline 69.3 kg) was reduced by 2.2 and 3.9 kg with semaglutide 0.5 and 1.0 mg, respectively (ETD –2.22 kg [–3.02; –1.42] and –3.88 kg [–4.70; –3.07]; both p<0.0001).