Novo Nordisk announces results for SUSTAIN2 trial of semaglutide
Posted: 17 December 2015 | | No comments yet
The trial investigated the efficacy and safety of semaglutide compared with sitagliptin after 56 weeks of treatment in people with type 2 diabetes…
Novo Nordisk has announced the headline results from the fourth Phase 3a SUSTAIN2 trial for semaglutide in people with type 2 diabetes.
The trial investigated the efficacy and safety of 0.5 mg and 1.0 mg semaglutide compared with 100 mg sitagliptin after 56 weeks of treatment, where both drugs were added on to metformin, thiazolidinedione (TZD) or a combination of metformin/TZD.
The trial successfully achieved its objective by demonstrating that from a mean baseline HbA1c of 8.1%, people treated with 0.5 mg or 1.0 mg semaglutide achieved a statistically significant and superior improvement in HbA1c of 1.3% and 1.6% respectively, compared to an improvement in HbA1c of 0.5% with 100 mg sitagliptin.
69% of the people treated with 0.5 mg semaglutide and 78% of the people treated with 1.0 mg semaglutide achieved the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) treatment target of HbA1c below 7% compared with 36% of the people treated with 100 mg sitagliptin.
People treated with semaglutide experienced statistically superior weight loss
Furthermore, from a mean baseline body weight of 89 kg, people treated with 0.5 mg and 1.0 mg semaglutide experienced a statistically significant and superior weight loss of 4.3 kg and 6.1 kg respectively, compared with a weight loss of 1.9 kg for people treated with 100 mg sitagliptin.
In the trial, semaglutide appeared to have a safe and well-tolerated profile.
“We are excited about the results of SUSTAIN 2, showing superior efficacy in glycaemic control and weight loss with semaglutide administered once-weekly compared with 100 mg sitagliptin, which is consistent with the outcome seen across all SUSTAIN trials reported to date,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “The results from the SUSTAIN programme thus far support that semaglutide has the potential to become the most efficacious GLP-1 product for people with type 2 diabetes.”
Novo Nordisk expects to announce headline results of the two remaining SUSTAIN trials in the first half of 2016.