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. 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.
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%. 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.
“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. 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.
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.