Treatment with Saxenda for three years reduced the risk of developing type 2 diabetes
Posted: 27 May 2015 |
The SCALE Obesity and Prediabetes trial met its primary endpoint, demonstrating that ongoing treatment with Saxenda delayed the onset of type 2 diabetes…
Novo Nordisk has announced the headline results from the SCALE Obesity and Prediabetes three-year extension trial in adults with obesity or who were overweight with comorbidities, and had prediabetes at baseline.
The trial met its primary endpoint, demonstrating that ongoing treatment with Saxenda® (liraglutide 3 mg) in combination with a reduced-calorie diet and increased physical activity delayed the onset of type 2 diabetes, compared with placebo (diet and exercise alone).
Onset of type 2 diabetes was 2.6 times longer with Saxenda compared with placebo
Over the course of this 160-week, randomised, blinded phase 3a trial, the time to onset of type 2 diabetes was 2.6 times longer with Saxenda compared with placebo treatment. In addition, the risk of developing type 2 diabetes was reduced by approximately 80% and statistically significant for those being treated with Saxenda.
“People with obesity are at an increased risk of developing type 2 diabetes, which is a serious disease,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer. “We are encouraged by these three-year data demonstrating that Saxenda® can help to delay the onset of type 2 diabetes, in addition to providing sustained long-term weight loss.”
49.6% of patients treated with Saxenda achieved clinically meaningful weight loss of at least 5% of their baseline body weight
At 160 weeks, Saxenda provided an average body weight loss of 6.1% from baseline, compared with 1.8% for placebo treatment, both in combination with a reduced calorie diet and increased physical activity. 49.6% of people treated with Saxenda achieved a clinically meaningful weight loss of at least 5% of their baseline body weight, compared with 23.4% on placebo treatment; 24.3% lost more than 10% of their body weight when treated with Saxenda compared to 9.4% with placebo.
In the trial, Saxenda was generally well tolerated and no new safety issues were identified. The 160-week completion rate was 52.6% and 45.0% for Saxenda and placebo, respectively. Withdrawals due to adverse events were 12.7% with Saxenda and 5.7% with placebo, and the most frequently reported adverse events were gastrointestinal in nature.