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Novo Nordisk issues semaglutide Phase 3 clinical trial results

Findings from a phase 3a clinical trial for semaglutide, an investigational glucagon-like peptide-1 analogue, demonstrated that treatment with semaglutide, administered once-weekly, significantly improved glycemic control compared to insulin glargine U100 in adults with type 2 diabetes.

Results from the SUSTAIN 4 trial were presented at the American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress in Orlando, Fla.

The 30-week SUSTAIN 4 trial showed that, from a mean baseline HbA1c of 8.2%, adults with type 2 diabetes receiving metformin with or without sulfonylurea, achieved statistically significant and superior improvements in HbA1c reductions of 1.2% and 1.6% when treated with 0.5 mg and 1.0 mg semaglutide, respectively, vs a 0.8% reduction with insulin glargine U100 (pless than0.0001 for both).

End of trial mean dose of insulin glargine U100 was 29 IU/day. More adults treated with 0.5 mg and 1.0 mg semaglutide achieved HbA1c targets compared with insulin glargine U100: HbA1c less than7% (57.5% and 73.3% vs 38.1%) and less than or equal to6.5% (37.3% and 54.2% vs 17.5%).

Additionally, from a mean baseline body weight of 93.4 kg/205.91 lb, adults treated with 0.5 mg and 1.0 mg semaglutide achieved statistically significant and superior reductions in mean body weight of 3.5 kg/7.72 lb and 5.2 kg/11.46 lb compared to an increase of 1.2 kg/2.65 lb with insulin glargine U100 (pless than0.0001 for both).

The most common adverse events observed for adults treated with 0.5 mg and 1.0 mg semaglutide were gastrointestinal (nausea: 21.3% and 22.2% vs insulin glargine U100, 3.6%; diarrhea: 16.3% and 19.2% vs insulin glargine U100, 4.4%; vomiting: 6.6% and 10.3% vs insulin glargine U100, 3.1%).

Rates of serious adverse events were comparable across treatment groups (6.1% and 4.7% vs 5.0%). Fewer adults reported severe or blood glucose-confirmed hypoglycemia with either semaglutide dose compared to insulin glargine U100 (4.4% and 5.6% vs 10.6%). The proportion of adults treated with 0.5 mg and 1.0 mg semaglutide discontinuing treatment due to adverse events was 5.5% and 7.5% vs 1.1%) for insulin glargine U100.



http://www.prnewswire.com/news-releases/semaglutide-demonstrated-superior-glycemic-control-vs-insulin-glargine-u100-in-adults-with-type-2-diabetes-300276365.html

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