medwireNews: Semaglutide significantly improves glycemic control and reduces bodyweight in treatment-naïve patients with type 2 diabetes, results of the placebo-controlled SUSTAIN 1 trial suggest.
The phase IIIa trial findings indicate that the glucagon-like peptide-1 (GLP-1) analog represents “a potential treatment option” for patients with type 2 diabetes, providing “a high degree of glycaemic control,” say Christopher Sorli (Billings Clinic Research Center, Montana, USA) and study co-authors.
Glycated hemoglobin (HbA1c) levels decreased by a significant 1.45% from baseline to week 30 among 128 patients randomly assigned to receive semaglutide 0.5 mg/week and by a significant 1.55% among 130 patients treated with semaglutide 1.0 mg/week, compared with a nonsignificant 0.02% decrease in 129 patients treated with placebo.
Furthermore, approximately three-quarters of patients receiving semaglutide at either dose achieved an HbA1c level below 7.0% (74% in the 0.5 mg group and 72% in the 1 mg group), whereas only a quarter of patients in the placebo group met this target. Mean baseline levels of HbA1c were 8.09% in the 0.5 mg group, 8.12% in the 1.0 mg group, and 7.95% in the placebo group.
In all, 66% of patients in the semaglutide 0.5 mg group and 65% in the semaglutide 1 mg group reached the target HbA1c level without severe or blood glucose-confirmed hypoglycemia and without weight gain, compared with 19% in the placebo group, suggesting that “semaglutide might potentially ameliorate several of the negative health consequences of type 2 diabetes,” say the researchers in The Lancet Diabetes & Endocrinology.
Participants’ mean body weight at study entry was 89.91 kg, 96.87 kg, and 89.05 kg in the 0.5 mg, 1.0 mg, and placebo groups, respectively, and decreased by a significant 3.73 kg and 4.53 kg in the 0.5 mg and 1.0 mg groups from baseline to week 30. In patients receiving placebo, body weight decreased by a nonsignificant 0.98 kg.
André Scheen (University of Liège, Belgium) notes in an accompanying editorial that semaglutide had a “similar safety profile to the other GLP-1 receptor agonists currently used for the management of type 2 diabetes,” but its effects on weight loss “seem more substantial.”
The most commonly reported adverse events in the SUSTAIN 1 trial were gastrointestinal (GI) events, including nausea, vomiting, and diarrhea, which were experienced by 38% of patients receiving 0.5 mg semaglutide, 38% of those receiving 1 mg semaglutide, and 15% of those receiving placebo. A respective 4%, 3%, and <1% of patients in the three groups experienced GI events leading to premature treatment discontinuation.
Although Scheen discusses the safety and efficacy of semaglutide in comparison with current treatments, he acknowledges that “indirect comparisons should be interpreted with caution.”
And he emphasizes that “only head-to-head trials would be able to clearly show the superiority of semaglutide over other GLP-1 receptor agonists.”
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