PLAINSBORO, N.J., March 4, 2019 /PRNewswire/ — Novo Nordisk today 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) injection 1 mg in combination with SGLT-2 inhibitor (SGLT-2i) therapy.1 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.1 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%.1 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.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®combined with an SGLT-2 inhibitor is effective in lowering blood sugar and reducing body weight [as a secondary endpoint]. These data further reinforce the results from across the SUSTAIN clinical development program 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 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).1 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).1
In 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.1
Ozempic® (semaglutide) injection 0.5 mg or 1 mg is a once-weekly glucagon-like peptide (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.2 Ozempic® was approved by the U.S. Food and Drug Administration on December 5, 2017, by Health Canada on January 4, 2018, by the European Commission on February 9, 2018, by the Japanese Ministry of Health, Labour and Welfare on March 23, by Swissmedic on July 2, 2018, and by the Brazilian National Health Surveillance Agency on August 6, 2018.3-8
About SUSTAIN 9
SUSTAIN 9 is a double-blind, randomized, parallel-group Phase 3b trial, which included 302 adults with type 2 diabetes, conducted across six countries. Adults with type 2 diabetes and A1C 7.0–10.0% treated with a stable dose (≥90 days’ treatment) of an SGLT-2 inhibitor, either as monotherapy or in combination with either metformin (71.5%) or sulfonylurea (12.9%), were randomized 1:1 to receive once-weekly Ozempic® (semaglutide) injection 1 mg, or a volume-matched placebo for 30 weeks. The primary endpoint was changed in A1C from baseline at Week 30. The primary and confirmatory analysis were based on Multiple Imputation (MI) followed by ANCOVA.
About the SUSTAIN clinical trial program
The SUSTAIN clinical development program 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 program involves more than 8,700 adults with type 2 diabetes in total (includes people from SUSTAIN 1-7 and 9).
What is Ozempic®?
Ozempic® (semaglutide) injection 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.
- Ozempic® is not recommended as the first choice of medicine for treating diabetes. It is not known if Ozempic® can be used in people who have had pancreatitis.
- Ozempic® is not a substitute for insulin and is not for use in people with type 1 diabetes or people with diabetic ketoacidosis.
- It is not known if Ozempic® is safe and effective for use in children under 18 years of age.
Mar 04, 2019