Novo Nordisk has reported positive results from the Phase IIIb SUSTAIN 9 clinical trial evaluating Ozempic (semaglutide) when added to an SGLT-2 inhibitor (SGLT-2i) in adults living with type 2 diabetes.
Ozempic is a once-weekly human glucagon-like peptide-1 (GLP-1) analogue intended to be used as an adjunct to diet and exercise for improving glycaemic control in type 2 diabetes patients.
The trial met its primary endpoint with a statistically significant and superior reduction of 1.5% in HbA1c, compared to 0.1% with placebo, both given in combination with SGLT2-i therapy.
A secondary endpoint analysis revealed statistically significant and superior decrease in body weight of 4.7kg, which was found to be 0.9kg in placebo group.
Novo Nordisk executive vice-president and chief science officer Mads Krogsgaard Thomsen said: “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.”
The double-blind, randomised, parallel-group SUSTAIN 9 trial evaluated the safety and efficacy of 1mg Ozempic with SGLT-2i therapy, as monotherapy or in combination with metformin or sulfonylurea, over 30 weeks.
Primary outcome of the Phase IIIb study was a change in HbA1c from baseline at week 30.
SUSTAIN 9 is part of Ozempic’s SUSTAIN clinical development programme involving ten Phase III trials, including a cardiovascular outcomes study in type 2 diabetes patients with high cardiovascular risk.