London, UK, 16 September, 2016 – New findings from two phase 3 clinical trials, SUSTAIN 5 and SUSTAIN 6, have shown that adults with type 2 diabetes treated with semaglutide, an investigational glucagon-like peptide-1 (GLP-1) receptor agonist administered once-weekly, experienced significantly improved glycaemic control and weight reduction1,2. In addition the SUSTAIN 6 trial showed that semaglutide significantly reduced the risk of the composite primary endpoint of cardiovascular (CV) death, non-fatal myocardial infarction (heart attack) or non-fatal stroke by 26% vs placebo (hazard ratio [HR]=0.74, 95% confidence interval [CI]: 0.58; 0.95; p<0.001 for non-inferiority) when added to standard of care2.
The results of the SUSTAIN 51 trial were presented earlier this week at the 52nd European Association for the Study of Diabetes (EASD) Annual Meeting, in Munich, Germany, demonstrating statistically significant and superior improvement in HbA1c for 0.5mg (ETD -1.35%, 95% CI: -1.61;-1.10) and for 1.0mg (ETD -1.75%, 95% CI:-2.01;-1.50) vs placebo respectively) and weight reduction for 0.5 mg (ETD -2.28 kg, 95% CI: -3.33;-1.29) and for 1.0mg (ETD -5.03 kg, 95% CI: -6.08;-4.04) vs placebo respectively1. SUSTAIN 62 results, announced today, demonstrate the cardiovascular safety of semaglutide over a period of up to 2 years in more than 3,000 adults with type 2 diabetes at high risk of major CV events, when added to standard of care2.
Semaglutide is the first once-weekly GLP-1 receptor agonist shown to significantly reduce the risk of CV events2. This follows positive CV outcomes data from the LEADER trial for once-daily GLP-1 receptor agonist Victoza® (liraglutide) earlier this year4. Adults with type 2 diabetes have approximately double the risk of developing cardiovascular disease (including heart disease and stroke), compared to people who do not have diabetes3.
“It is important that adults with type 2 diabetes have confidence that their diabetes treatments can help them reach their individualised treatment goals and that won’t add to their existing risk of CV complications,” commented Professor Steve Bain, National lead for SUSTAIN 6, Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit, Wales. “What we’re seeing from the semaglutide trials has surpassed our expectations, as not only do we have a significantly higher proportion of patients hitting an HbA1c target of under 7% and weight loss with semaglutide compared to placebo, we have the added reassurance of reduced CV risk.”
In SUSTAIN 5, adults with type 2 diabetes on 0.5 mg and 1.0 mg semaglutide as add-on to basal insulin alone or basal insulin in combination with metformin achieved1:
In SUSTAIN 6, adults with type 2 diabetes on 0.5 mg and 1.0 mg semaglutide achieved2:
“The results of SUSTAIN trials further support the strong potential of once-weekly semaglutide in type 2 diabetes treatment and we look forward to regulatory submission later this year,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The SUSTAIN 6 results strengthen the clinical evidence for the Novo Nordisk GLP-1 receptor agonist portfolio with the finding of additional benefits beyond glycaemic control and weight loss in adults with type 2 diabetes at high cardiovascular risk.”
In SUSTAIN 5, adverse events were reported for 68.9% and 64.1% of adults treated with 0.5 mg and 1.0 mg semaglutide, respectively, and for 57.9% of adults treated with placebo. The most common adverse events observed for adults treated with 0.5 mg and 1.0 mg semaglutide were nausea (11.4% and 16.8% respectively vs 4.5% in the placebo group) and severe or blood glucose-confirmed symptomatic hypoglycaemia (8.3% and 10.7% respectively vs 5.3% in the placebo group). The proportions of adults discontinuing 0.5 mg or 1.0 mg semaglutide due to adverse events were 4.5% and 6.1% respectively vs 0.8% in the placebo group1.
In SUSTAIN 62, adverse events were reported for 89.6% and 89.1% of adults treated with 0.5 mg and 1.0 mg semaglutide, respectively, and for 90.8% and 89.2% of adults treated with 0.5 mg and 1.0 mg placebo respectively. Significantly fewer people treated with semaglutide had new onset or worsening nephropathy (3.8% vs 6.1% with placebo) (HR, 0.64, 95% CI: 0.40; 0.88, p=0.005) while significantly more people treated with semaglutide experienced diabetic retinopathy complications (3.0% vs 1.8% with placebo) (HR, 1.76, 95% CI: 1.11; 2.78; p=0.02). The incidence of both hypoglycaemia and pancreatitis was similar with both semaglutide vs placebo2.
NOTES TO EDITORS
Semaglutide is an investigational analogue of native human glucagon-like peptide-1 (GLP-1) that stimulates insulin and suppresses glucagon secretion in a glucose-dependent manner, as well as decreases appetite and food intake.5 Semaglutide administered subcutaneously once-weekly is in phase 3 development for the treatment of adults with type 2 diabetes.
About SUSTAIN 51
SUSTAIN 5 was a double-blinded trial to investigate the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with placebo as add-on to basal insulin alone or basal insulin in combination with metformin, after 30 weeks of treatment in 397 people with type 2 diabetes.
About SUSTAIN 62
SUSTAIN 6 was a multicentre, international, randomised, double-blind, placebo-controlled pre-marketing CV outcomes trial (CVOT) investigating the long-term effects of semaglutide (0.5 mg and 1.0 mg) administered once-weekly, compared to placebo, when added to standard of care, in adults with type 2 diabetes at high risk of CV events. Standard of care included lifestyle modifications, glucose-lowering treatments and cardiovascular medications. The trial was initiated in February 2013 and randomised 3,297 adults with type 2 diabetes from 20 countries that were treated for 104 weeks.
SUSTAIN 6 is the first dedicated pre-marketing CVOT in a type 2 diabetes population to report data. SUSTAIN 6 was designed to assess non-inferiority, i.e. demonstrate no increased risk of major CV events vs placebo, when added to standard of care. Superiority testing was not part of the pre-specified analysis. The primary endpoint was the first occurrence of a composite CV outcome comprising CV death, non-fatal myocardial infarction or non-fatal stroke.
About the SUSTAIN clinical programme
SUSTAIN (Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes) is a clinical programme for semaglutide, administered once-weekly, that comprises six phase 3a global clinical trials encompassing more than 7,000 people with type 2 diabetes as well as two Japanese trials encompassing around 1,000 people with type 2 diabetes.
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders, and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit novonordisk.co.uk.
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1. Rodbard, H, Lingvay, I, Reed, J et al. Efficacy and safety of semaglutide onceweekly vs placebo as addon to basal insulin alone or in combination with metformin in subjects with type 2 diabetes (SUSTAIN 5). Poster number 766. European Association for the Study of Diabetes, Munich, Germany; 12-16 September 2016.
2. Marso SP, Bain S, Consoli A, et al. Semaglutide and cardiovascular outcomes, efficacy and safety in type 2 diabetes. New England Journal of Medicine. 2016; In Press.
3. Diabetes UK. State of the Nation 2015. https://www.diabetes.org.uk/Documents/About%20Us/What%20we%20say/State%20of%20the%20nation%202014.pdf (accessed September 2016).
4. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes (LEADER). Marso SP et al. N Engl J Med 2016. DOI: 10.1056/NEJMoa1603827
5. Nauck MA, Petrie JR, Sesti G, et al. A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes. Diabetes Care. 2015; 39:231-241.
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UK/SM/0916/0046 Date of preparation: September 2016
Last updated on: 23/09/2016
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