SUSTAIN 4 semaglutide clinical trial shows superiority over insulin glargine

28 May 2016

Positive findings from a Phase IIIa clinical trial for semaglutide, an investigational glucagon-like peptide-1 (GLP-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 Friday at the American Association of Clinical Endocrinologists 25th Annual Scientific and Clinical Congress (AACE) in Orlando, US, said the drug’s developer, Danish diabetes care giant Novo Nordisk (NOV: N). Insulin glargine is French pharma major Sanofi’s (Euronext: SAN) brand Lantus.

The 30-week SUSTAIN 4 trial showed that, from a mean baseline HbA_1c of 8.2%, adults with type 2 diabetes receiving metformin with or without sulfonylurea, achieved statistically-significant and superior improvements in HbA_1c reductions of 1.2% and 1.6% when treated with 0.5mg and 1.0 mg semaglutide, respectively, versus a 0.8% reduction with insulin glargine U100 (p<0.0001 for both).
More adults treated with 0.5mg and 1.0 mg semaglutide achieved HbA_1c targets compared with insulin glargine U100: HbA_1c <7% (57.5% and 73.3% vs 38.1%) and ≤6.5% (37.3% and 54.2% vs 17.5%).
From a mean baseline body weight of 93.4kg, adults treated with 0.5mg and 1.0mg semaglutide achieved statistically-significant and superior reductions in mean body weight of 3.5kg and 5.2kg compared to an increase of 1.2kg with insulin glargine U100 (p<0.0001 for both).

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