According to results from the SUSTAIN trial, the addition of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, to a sodium-glucose cotransporter-2 (SGLT-2) inhibitor therapy led to significant improvements in glycemic control, as well as weight reduction, in patients with inadequately controlled type 2 diabetes (T2D).
In this double-blind, parallel-group phase 3b study, 302 T2D patients taking SGLT-2 inhibitors, either as monotherapy or in combination with metformin or sulfonylurea, were randomized to receive semaglutide 1mg injection once-weekly or placebo for 30 weeks; the primary endpoint of the study was change in HbA1c from baseline at week 30.
Results showed that patients treated with semaglutide had statistically significant and greater reductions in HbA1c compared with placebo (estimated treatment difference: -1.42% [95% CI, -1.61 to -1.24]; P<.0001). In addition, patients in the semaglutide group had greater reductions in body weight than those in the placebo arm (estimated treatment difference: -3.81kg [95% CI, -4.70 to -2.93]; P<.0001).
With regard to safety, gastrointestinal adverse events (AEs) were found to be most common, with 37.3% of semaglutide-treated patients and 13.2% of placebo patients experiencing these AEs. As for serious AEs, hypoglycemic events (severe or blood glucose-confirmed) were reported in 2.7% of semaglutide-treated patients vs 0% for placebo.
Semaglutide is marketed under the brand name Ozempic (Novo Nordisk) and is currently approved as an adjunct to diet and exercise to improve glycemic control in adults with T2D. It is available as a solution for subcutaneous injection using a prefilled pen injector.
“The results from SUSTAIN 9 demonstrated that Ozempic combined with an SGLT-2 inhibitor is effective in lowering blood sugar and reducing body weight [as a secondary endpoint],” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “These data further reinforce the results from across the SUSTAIN clinical development program and the benefits of Ozempic that clinicians from many countries are already seeing in their day-to-day practices.”
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