Novo Nordisk’s Ozempic (semaglutide), in combination to SGLT-2 inhibitor (SGLT-2i) therapy, met the primary endpoint in a phase 3 trial in patients with type 2 diabetes.
The 30-week long trial, dubbed Sustain 9, assessed the efficacy and safety of Ozempic injection 1.0 mg in combination with the SGLT-2 inhibitors against placebo.
The drug was demonstrated to be superior in lowering both blood sugar and weight in comparison to placebo in the trial, which enrolled 302 adults with type 2 diabetes and was held across six countries.
Patients in the late-stage trial were randomly grouped to be subjected to weekly once of the Novo Nordisk drug or placebo in addition to an SGLT-2i, as monotherapy or in combination with metformin or sulfonylurea.
The Ozempic arm showed a statistically significant and superior reduction in HbA1c of 1.5% vs 0.1% with placebo, in combination with SGLT2-i treatment and also from an overall mean baseline of 8.0%.
As per additional findings of a secondary endpoint, the Novo Nordisk drug showed a statistically significant and superior reduction in body weight of 4.7kg compared to 0.9kg registered by placebo, from an overall mean baseline of 91.7kg.
Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said: “Despite current treatment, almost 50% of people with type 2 diabetes are still living with uncontrolled blood sugar.
“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.”
Ozempic is a once-weekly analogue of human glucagon-like peptide-1 (GLP-1). It is indicated in the US and in the European Union and other countries as an adjunct to diet and exercise to increase glycaemic control in adults with type 2 diabetes.
Its SUSTAIN clinical development program comprises 10 phase 3 clinical trials, which included a cardiovascular outcomes trial featuring type 2 diabetes patients with high cardiovascular risk. Overall, the SUSTAIN program involved over 8,700 adults with type 2 diabetes.