Novo Nordisk's experimental diabetes drug semaglutide meets main goal in late-stage study

Novo Nordisk announced results from the Phase IIIa SUSTAIN 1 trial Friday demonstrating that its experimental GLP-1 analogue semaglutide led to "superior" improvements in HbA1c and weight loss, compared with placebo. Mads Krogsgaard Thomsen, the company's chief scientific officer, said the findings "confirm that semaglutide has the potential to help people with type 2 diabetes achieve both good glycaemic control and a significant weight loss with one weekly injection."

In the study, 388 drug-naïve patients with type 2 diabetes were randomised to treatment with one of two doses of semaglutide administered once weekly as monotherapy, or placebo for 30 weeks. Results showed that the low and high doses of semaglutide were associated with HbA1c reductions of 1.5 percent and 1.6 percent, respectively, compared to no change in the placebo arm. Further, 74 percent and 73 percent of patients treated with the respective low and high doses of semaglutide achieved the American Diabetes Association and European Association for the Study of Diabetes treatment target of HbA1c of less than 7 percent, versus 25 percent of the placebo-treated patients.

In addition, patients in the respective low and high dosage groups experienced weight loss of 3.8 kg and 4.6 kg, respectively, compared to 1.0 kg for patients in the placebo arm. Novo Nordisk also said the drug had a safe and well-tolerated profile, with the most common adverse events affecting the gastrointestinal system. The company noted that the side effects "were comparable to Victoza (liraglutide) in similar trials and diminished over time."

The drugmaker said results from the remaining five trials in the Phase III SUSTAIN programme will be released in the next nine months.

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