Novo Nordisk announces positive phase 2 trial results for type 2 diabetes treatment

Novo Nordisk has announced its headline results from a phase 2 clinical trial with CagriSema – a once-weekly subcutaneous combination of semaglutide and a novel amylin analogue, cagrilintide – in people with type 2 diabetes.

The trial investigated the efficacy and safety of a fixed dose combination of CagriSema – 2.4mg semaglutide and 2.4mg cagrilintide – compared to the individual components semaglutide 2.4mg and cagrilintide 2.4mg, all administered once-weekly, in 92 people with type 2 diabetes and who are overweight.

People treated with CagriSema achieved a numerically higher HbA1c reduction of 2.18%-points compared to a reduction of 1.79%-points for people treated with semaglutide and 0.93%-points with cagrilintide alone, after 32 weeks of treatment.

Moreover, people treated with CagriSema achieved a numerically higher body weight reduction of 15.6% compared to a reduction of 5.1% for people treated with semaglutide and 8.1% with cagrilintide alone. CagriSema appeared to have a safe and well-tolerated profile in the trial.

More than 4.9 million people in the UK have diabetes, around 90% of which have type 2 diabetes, according to Diabetes UK. There is currently no cure for type 2 diabetes, with current treatment options focused on disease management, including diet and exercise, diabetes medications or insulin therapy.

Commenting on the positive results, Martin Holst Lange, executive vice president for development at Novo Nordisk, said: "We are encouraged by the impressive phase 2 results for CagriSema in people with type 2 diabetes. The results indicate that CagriSema reduces blood sugar more than semaglutide alone and the weight loss seen in the trial confirms the substantial weight lowering potential of CagriSema.”

Novo Nordisk has outlined its plans to initiate a phase 3 development programme for CagriSema in people with type 2 diabetes in 2023. The CagriSema – 2.4mg semaglutide and 2.4mg cagrilintide – phase 3 programme in people with overweight and obesity, REDEFINE, is expected to begin in the fourth quarter of 2022.

Last month, the company also announced positive results from the ONWARDS 3 AND ONWARDS 4 phase 3a trials with once-weekly insulin Icodec in adults with type 2 diabetes. The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 26 with insulin Icodec compared with insulin Tresiba (degludec).