Bagsværd, Denmark, 28 April 2016 - Novo Nordisk today announced the top-line results from the sixth and last global phase 3a trial, SUSTAIN6, for semaglutide; a new GLP-1 analogue, which is administered subcutaneously once weekly in the SUSTAIN trials. This double-blinded 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.
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.
"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" says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "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.
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. Semaglutide administered subcutaneously once weekly is in phase 3 development for the treatment of type 2 diabetes. Furthermore, semaglutide is currently being developed in an oral tablet version for treatment of type 2 diabetes as well as in once-daily subcutaneous versions for treatment of type 2 diabetes and weight management.
About the SUSTAIN clinical programme
The SUSTAIN programme is a phase 3 clinical programme comprising six global trials of semaglutide administered subcutaneously once weekly encompassing more than 7,000 people with type 2 diabetes.
SUSTAIN 1 - a 30-week efficacy and safety trial of semaglutide versus placebo in 388 drug-naïve people with type 2 diabetes. The results were reported in July 2015.
SUSTAIN 2 - a 56-week efficacy and safety trial of semaglutide versus sitagliptin once-daily as add-on to metformin and/or TZD in 1,231 people with type 2 diabetes. The results were reported in December 2015.
SUSTAIN 3 - a 56-week efficacy and safety trial of semaglutide versus 2.0 mg exenatide once-weekly as add-on to 1-2 oral antidiabetic drugs in 813 people with type 2 diabetes. The results were reported in September 2015.
SUSTAIN 4 - a 30-week efficacy and safety trial of semaglutide versus insulin glargine once-daily as add-on to metformin with or without sulfonylurea in 1,089 insulin-naïve people with type 2 diabetes. The results were reported in November 2015.
SUSTAIN 5 - a 30-week efficacy and safety trial of semaglutide versus placebo as add-on to basal insulin alone or basal insulin in combination with metformin in 397 people with type 2 diabetes. The results were reported in February 2016.
SUSTAIN 6 - a 2-year trial to evaluate cardiovascular and other long-term outcomes with semaglutide in approximately 3,300 people with type 2 diabetes.
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Company announcement No 31 / 2016