TrialWatch: Novo Nordisk’s SUSTAIN 9 Trial Meets Primary Endpoint

Mar 5, 2019 | Diabetes, Diabetes Type 2, Ozempic, Positive Results, Semaglutide

Novo Nordisk’s SUSTAIN 9 trial was conducted in Asia, Europe and North America. The aim of the trial was to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects would remain on their pre-trial medication. The pharmaceutical company established over 70 research sites for this Phase 3 trial.

The Phase 3b results were recently announced via press release and published in The Lancet Diabetes & Endocrinology by the Danish industry sponsor. The objective of this 30-week trial was to assess the efficacy and safety of Ozempic® (semaglutide) injection 1 mg in combination with SGLT-2 inhibitor (SGLT-2i) therapy. In SUSTAIN 9, adults with type 2 diabetes were randomized to receive once-weekly semaglutide or placebo in addition to an SGLT-2i, either as monotherapy or in combination with metformin or a sulfonylurea. Ozempic® (semaglutide) 0.5 mg or 1 mg is an injectable prescription medicine for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

The trial met its primary endpoint, with Ozempic® (semaglutide) injection 1 mg demonstrating a statistically significant and superior reduction in A1C of 1.5% vs 0.1% with placebo (p<0.0001), both in combination with SGLT2-i treatment, from an overall mean baseline of 8.0%. Additional findings of a secondary endpoint showed that Ozempic® 1 mg demonstrated a statistically significant and superior reduction in body weight of 4.7 kg vs 0.9 kg with placebo (p<0.0001), from an overall mean baseline of 91.7 kg. Within the study, a statistically significant greater proportion of people treated with Ozempic® 1 mg vs placebo, both in combination with an SGLT-2i, achieved the American Diabetes Association (ADA) A1C target of <7% (<53 mmol/mol), with 78.7% vs 18.7%, respectively (p<0.0001). A statistically significant greater proportion of people also met the more stringent American Association of Clinical Endocrinologists (AACE) A1C target of ≤6.5% (≤48 mmol/mol) with Ozempic® 1 mg vs placebo, both combined with an SGLT-2i, with 56.1% vs 3.9% respectively (p<0.0001).1In SUSTAIN 9, the safety profile of Ozempic® 1 mg in combination with SGLT-2i therapy was consistent with the overall SUSTAIN program. The most common adverse event (AE) for Ozempic® 1 mg was nausea. Gastrointestinal AEs were reported in 37.3% and 13.2% of people treated with Ozempic® 1 mg and placebo, respectively. Serious AEs occurred in 4.7% and 4.0% of people, respectively. Severe or blood glucose–confirmed hypoglycemic events were reported in 4 people treated with Ozempic® 1 mg (2.7%) vs 0 people with placebo.

Ozempic Background

Semaglutide (USAN; trade name Ozempic) is a pharmaceutical drug developed by Danish company Novo Nordisk for the treatment of type 2 diabetes. It is marketed by the name Ozempic. As a glucagon-like peptide-1 receptor agonist, it lowers the blood sugar level by increasing the production of insulin. It was discovered in 2012, by a team of researchers at Novo Nordisk as a longer-acting alternative to liraglutide. Clinical trials were started in 2015, and phase 3 was completed in 2016. Researchers at the University of Leeds and Novo Nordisk reported in 2017 that it can also be used for the treatment of obesity. It reduces hunger, food craving and body fat. FDA approval was applied in December 2016, and in October 2017 FDA Advisory Committee voted 16–0 in favor. On December 5, 2017, semaglutide was approved by the US FDA. It can be used as both injection-type or oral-type drug. The marketing authorization in EU was granted on 8 February 2018. It is still under review by regulatory authorities in Japan, pending approval.


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