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Study: Treatment With Saxenda (Liraglutide) for 3 Years Reduces Risk of Type-2 Diabetes
Positive results have been reported from the SCALE (Satiety and Clinical Adiposity –– Liraglutide Evidence in Nondiabetic and Diabetic People) obesity and prediabetes 3-year extension trial in adults with obesity or who were overweight with comorbidities, and who had prediabetes at baseline. The trial met its primary endpoint, demonstrating that ongoing treatment with Saxenda (liraglutide 3 mg, Novo Nordisk) in combination with a reduced-calorie diet and increased physical activity delayed the onset of type-2 diabetes compared with placebo (i.e., diet and exercise alone).
Over the course of this 160-week, randomized, blinded study, the time to onset of type-2 diabetes was 2.6 times longer with liraglutide injection than with placebo. In addition, the risk of developing type-2 diabetes was reduced by approximately 80% among those treated with liraglutide (P < 0.0001).
At 160 weeks, liraglutide provided an average body-weight loss of 6.1% from baseline compared with a loss of 1.8% for placebo (P < 0.0001), both in combination with a reduced- calorie diet and increased physical activity. Clinically meaningful weight loss of at least 5% of their baseline body weight was achieved by 49.6% of the patients treated with liraglutide compared with 23.4% of those given placebo. Similarly, 24.3% of the liraglutide group lost more than 10% of their body weight compared with 9.4% of the placebo group.
Liraglutide was generally well tolerated, and no new safety issues were identified. The 160-week completion rates were 52.6% and 45.0% for liraglutide and placebo, respectively. Withdrawal rates due to adverse events were 12.7% with liraglutide and 5.7% with placebo, and the most common adverse events were gastrointestinal in nature.
The SCALE obesity and prediabetes trial was a randomized, double-blind, placebo-controlled, multinational study in nondiabetic adults with obesity and nondiabetic adults who were overweight with comorbidities. A total of 3,731 participants were randomly assigned to treatment with liraglutide 3 mg or placebo in combination with a reduced-calorie diet and increased physical activity. In addition, participants were further stratified to 56 weeks or 160 weeks of treatment based on their prediabetes status at baseline screening.
Liraglutide is a once-daily glucagon-like peptide-1 (GLP-1) analogue with 97% similarity to naturally occurring human GLP-1, a hormone that is released in response to food intake. Like human GLP-1, liraglutide regulates the patient’s appetite by increasing feelings of fullness and satiety, while lowering feelings of hunger and prospective food consumption, thereby leading to reduced food intake. As with other GLP-1 receptor agonists, liraglutide stimulates insulin secretion and lowers glucagon secretion in a glucose-dependent manner. These effects can lead to a reduction of fasting and post-prandial blood glucose.
Saxenda was approved by the FDA in December 2014.
Source: Novo Nordisk; May 22, 2015.