Efficacy and Safety of Once-Weekly Semaglutide 2.0 mg Versus 1.0 mg in Patients With Type 2 Diabetes (SUSTAIN FORTE): A Double-Blind, Randomised, Phase 3B Trial
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Safety signals identified through extended follow-up include: Gastrointestinal effects : Nausea, vomiting, and diarrhea remain the most common adverse events, typically diminishing over time but causing discontinuation in approximately 57% of patients Gallbladder disease : Increased incidence of cholelithiasis and cholecystitis, possibly associated with weight loss, though the exact mechanism remains under investigation Diabetic retinopathy : Risk of complications, particularly with rapid glycemic improvement in patients with pre-existing retinopathy Acute kidney injury : Risk associated with severe gastrointestinal adverse events leading to dehydration Pancreatitis : Rare cases reported, though causality remains uncertain
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Furthermore, subjects in the multiple-dose trial fasted for 2 h after each dosing of oral semaglutide, while the more recent dosing guidance used in the phase III trials requests subjects to fast for at least 30 min after dosing