- Cancer Biology & Biomarkers
- Chromatography & Mass Spectrometry
- Contract Research, Clinical Trials and Outsourcing
- Drug Discovery
- Drug Targets
- Flow Cytometry
- Informatics & Lab Automation
- Ingredients, Excipients and Dosages
- Microbiology & RMMs
- NIR, PAT & QbD
- Raman Spectroscopy
- Screening, Assays & High-Content Analysis
- Thermal Processing
- Events & Workshops
Semaglutide reduces the risk of major adverse cardiovascular events in trial
28 April 2016 • Author: Victoria White, Digital Content Producer
Novo Nordisk has announced top-line results from the sixth and last global Phase IIIa trial, SUSTAIN6, for semaglutide.
Semaglutide is a new glucagon-like peptide-1 (GLP-1) analogue that can help people with type 2 diabetes achieve substantial improvement of blood glucose with a low risk of hypoglycaemia. In addition, semaglutide induces weight loss by decreasing appetite and food intake. The therapy was administered subcutaneously once weekly in the SUSTAIN trials.
The double-blinded SUSTAIN6 trial investigated the long-term cardiovascular and other safety outcomes of 0.5 mg and 1.0 mg semaglutide compared with placebo, both in addition to standard-of-care. In the trial, approximately 3,300 people with type 2 diabetes were treated for 104 weeks.
A statistically signficant reduction in cardiovascular risk
The trial achieved its primary endpoint of showing non-inferiority of major cardiovascular events (MACE) with semaglutide compared with placebo, as well as a statistically significant reduction in cardiovascular risk. In the trial, around 250 MACE were accrued. The primary endpoint of the study was defined as the composite outcome of the first occurrence of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
The safety profile of semaglutide in SUSTAIN 6 was as expected and consistent with previous semaglutide clinical studies.
Commenting on the results, Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “We are very encouraged by the potential for reduction of CV risk in people with type 2 diabetes with semaglutide based on the results of SUSTAIN 6. In addition to the strong efficacy profile, we have also established the safety profile for semaglutide by concluding the six SUSTAIN trials. With the strong results from SUSTAIN 6, we look forward to the regulatory filing of semaglutide.”
Novo Nordisk expects to file semaglutide for regulatory review in the US and EU in the fourth quarter of 2016.
ABB Analytical Measurement ACD/Labs ADInstruments Ltd Advanced Analytical Technologies GmbH Analytik Jena AG Astell Scientific Ltd Bachem AG Bibby Scientific Limited Bio-Rad Laboratories BioNavis Ltd Biopharma Group Black Swan Analysis Limited Charles Ischi AG | Kraemer Elektronik Cherwell Laboratories CI Precision Cobalt Light Systems Coulter Partners CPC Biotech srl Dassault Systèmes BIOVIA DiscoverX Edinburgh Instruments Enterprise System Partners (ESP) EUROGENTEC F.P.S. Food and Pharma Systems Srl IDBS JEOL Europe L.B. Bohle Maschinen + Verfahren GmbH Lab M Ltd. LabWare Linkam Scientific Instruments Limited Molins Technologies Multicore Dynamics Ltd Nanosurf New England Biolabs, Inc. Panasonic Biomedical Sales Europe B.V. PerkinElmer Inc ReAgent Russell Finex Limited Source BioScience Takara Clontech Tornado Spectral Systems Tuttnauer Watson-Marlow Fluid Technology Group Wickham Laboratories Limited Xylem Analytics YMC Europe GmbH Yusen Logistics