Novo Nordisk announced publication of results from the SUSTAIN 9 Phase 3b trial in The Lancet Diabetes & Endocrinology. The objective of this 30 week trial was to assess the efficacy and safety of Ozempic® (semaglutide) 1.0 mg when added to SGLT-2 inhibitor (SGLT-2i) therapy. (1) In SUSTAIN 9, adults with type 2 diabetes were randomised to receive once-weekly semaglutide or placebo in addition to an SGLT-2i, either as monotherapy or in combination with metformin or sulfonylurea.(1)
The trial met its primary endpoint, with Ozempic® (semaglutide) injection 1.0 mg demonstrating a statistically significant and superior reduction in HbA1c of 1.5% vs 0.1% with placebo, both in combination with SGLT2-i treatment, from an overall mean baseline of 8.0%.(1) Additional findings of a secondary endpoint showed that Ozempic® 1.0 mg demonstrated a statistically significant and superior reduction in body weight of 4.7 kg vs 0.9 kg with placebo, from an overall mean baseline of 91.7 kg.(1)
"Despite current treatment, almost 50% of people with type 2 diabetes are still living with uncontrolled blood sugar," said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The results from SUSTAIN 9 demonstrated that Ozempic® in combination with an SGLT-2 inhibitor is effective in lowering blood sugar and reducing body weight. These data further reinforce the results from across the SUSTAIN clinical development programme and the benefits of Ozempic® that clinicians from many countries are already seeing in their day-to-day practices."
Within the study, a statistically significant greater proportion of people treated with Ozempic® 1.0 mg vs placebo (both in combination with an SGLT-2i) achieved the American Diabetes Association (ADA) HbA1C target of <7% (<53 mmol/mol), with 78.7% vs 18.7%, respectively.(1) A statistically significant greater proportion also met the more stringent American Association of Clinical Endocrinologists (AACE) HbA1C target of <6.5% (<48 mmol/mol) with Ozempic® 1.0 mg vs placebo (both in combination with an SGLT-2i), with 56.1% vs 3.9% respectively.(1)
In SUSTAIN 9, the safety profile of Ozempic® 1.0 mg in combination with SGLT-2i therapy was consistent with the overall SUSTAIN clinical trial programme. The most common adverse event (AE) for Ozempic® was nausea. Gastrointestinal AEs were reported in 37.3% and 13.2% of people treated with Ozempic® 1.0 mg and placebo, respectively. Serious AEs occurred in 4.7% and 4.0% of people, respectively. Severe or blood glucose-confirmed hypoglycaemic events were reported in 4 people treated with Ozempic® 1.0 mg (2.7%) vs 0 people with placebo.(1)
About Ozempic®
Ozempic® (semaglutide) is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1) indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes.(2,3) Ozempic® was approved by the US Food and Drug Administration on 5 December 2017, by Health Canada on 4 January 2018, by the European Commission on 8 February 2018, by the Japanese Ministry of Health, Labour and Welfare on 23 March 2018, by Swissmedic on 2 July 2018, and by the Brazilian National Health Surveillance Agency on 6 August 2018.(4-9)
About SUSTAIN 9
SUSTAIN 9 is a double-blind, randomised, parallel-group Phase 3b trial, which included 302 adults with type 2 diabetes, conducted across six countries. Adults with type 2 diabetes and HbA1c 7.0-10.0%, with >90 days' treatment of an SGLT-2i, either as monotherapy or in combination with either metformin (71.5%) or sulfonylurea (12.9%), were randomised 1:1 to receive once-weekly Ozempic® (semaglutide) injection 1.0 mg, or a volume-matched placebo for 30 weeks. The primary outcome was change in HbA1c from baseline at Week 30. The primary and confirmatory analyses were based on Multiple Imputation (MI) followed by ANCOVA.(1)
About the SUSTAIN clinical trial programme
The SUSTAIN clinical development programme for Ozempic® comprises 10 Phase 3 global clinical trials, including a cardiovascular outcomes trial, which included people with type 2 diabetes and high cardiovascular risk. The programme involved more than 8,700 adults with type 2 diabetes in total (includes people from SUSTAIN 1-7 and 9).
About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 43,200 people in 80 countries and markets its products in more than 170 countries.
1. Zinman B, et al. Semaglutide once weekly as add-on to SGLT-2 inhibitor therapy in type 2 diabetes (SUSTAIN 9): a randomised, placebo-controlled trial. 2019. The Lancet Diabetes and Endocrinology. ePub ahead of print. DOI: https://doi.org/10.1016/S2213-8587(19)30066-X.
2. EMA. Ozempic® Summary of Product Characteristics. Available at: http://www.ema.europa.eu 2019.
3. FDA. Ozempic® US Prescribing Information. December 2017. Available at: http://www.novo-pi.com/ozempic.pdf Last accessed: March 2019.
4. Novo Nordisk. Ozempic® approved in Japan for the treatment of type 2 diabetes. Available at: https://www.novonordisk.com Last accessed: March 2019.
5. Novo Nordisk. Ozempic® approved in Canada for the treatment of adults with type 2 diabetes. Available at: http://www.novonordisk.ca Last accessed: March 2019.
6. Novo Nordisk. Company Announcement. Ozempic® (semaglutide) approved in the US. Available from: https://www.novonordisk.com. Last accessed: March 2019.
7. Novo Nordisk. Ozempic® (semaglutide) recommended for approval by the European regulatory authorities. Available at: https://www.novonordisk.com/content/Denmark/HQ/www-novonordisk-com/en_gb/home/media/news-details.2156392.html. Last accessed: March 2019.
8. Ozempic® (semaglutide) Brazil letter of marketing authorisation. August 2018.
9. Swissmedic. Ozempic® (semaglutide) approval. July 2018. Available at: https://www.swissmedic.ch/swissmedic/en/home. Last accessed: March 2019.