Patients who responded to medication had greater improvement in cardiometabolic risk factors.
Results from two separate SCALE trials were presented at the World Diabetes Congress with evidence supporting the efficacy of liraglutide. Obesity has been long understood to be a significant risk factor for the development of type 2 diabetes.
In the first study, SCALE Obesity and Prediabetes, researchers investigated the effects of liraglutide 3.0 mg, as adjunct to diet and exercise, on weight loss. The study is a randomized, double-blind and placebo-controlled 56-week study. The trial recruited 3,731 adults who had to have a BMI greater than or equal to 27 kg/m2 with greater than or equal to 1 comorbidity OR BMI greater than 30 kg/m2. The participants averaged 45.1 years, 78.5% female, body weight 106.2 kg, BMI 38.3 kg/m2, and 61.2% with prediabetes. Participants were randomized into two groups in a 2:1 ratio with one group receiving liraglutide 3.0 mg subcutaneously once daily or placebo. All adults were recommended a 500 kcal/day deficit diet and an exercise program. Of the groups, 71.9% on liraglutide and 64.4% on placebo completed the 56-week study.
Results of the SCALE Obesity and Prediabetes study shows that at the end of week 56, those on liraglutide lost significantly more weight than those on placebo and reduced the risk of developing diabetes. The liraglutide group (n=2432) lost an average of 8.0% (8.4 kg) body weight compared to 2.6% (2.8 kg) on placebo (n=1220) (P<0.0001). Of those who were prediabetic at screening, more individuals had reverted normoglycemia on liraglutide (69.7%) than on placebo (32.1%) (P<0.0001). Of those who were normoglycemic at screening, less individuals had progressed to prediabetes on liraglutide (6.9%) than on placebo (19.9%) (P<0.0001). The results of the study showed that liraglutide is superior to placebo as an adjunct to diet and exercise.
The second study, SCALE Diabetes, investigated the efficacy and safety of liraglutide for weight management. The study looked at adults who are overweight or obese and have type 2 diabetes. The study is a randomized, double-blind, and placebo-controlled 56-week study. There were 846 participants who were randomized into 3 groups: liraglutide 3.0 mg subcutaneous once daily, liraglutide 1.8 mg subcutaneous once daily, or placebo in a 2:1:1 ratio, respectively. The participants must have a BMI of 27.0 or greater, older than 18 years old, taking 0 to 3 oral hypoglycemic agents with stable body weight, and A1c level between 7% to 10%. All adults were recommended a 500 kcal/day deficit diet and an exercise program.
The results of SCALE Diabetes shows that at the end of week 56, liraglutide 3.0 mg had greater efficacy in weight loss and higher weight percentage loss than liraglutide 1.8 mg and placebo. The average weight loss at week 56 was 6% with liraglutide 3.0 mg, 4.7% with liraglutide 1.8 mg, and 2% with placebo. In those with weight loss of greater than 5%, liraglutide 3.0 mg (54.3%) had greater success than liraglutide 1.8 mg (40.4%) and placebo (21.4%). This study reflects the same results found in SCALE Obesity and Prediabetes.
When analyzing data from both trials, the data showed that 93.4% of early nonresponders will not achieve weight loss of 10% at the end of 56 weeks. Those who responded early to liraglutide saw greater improvement in cardiometabolic risk factors versus early nonresponders. The results from these studies show that obese patients who need to lose weight should use liraglutide for 16 weeks and continue liraglutide therapy if they show a response of greater than 5% weight loss at the end of 16 weeks.
Liraglutide can be used as therapy for patients who need to lose weight. This gives patients and physicians more options if one treatment plan is not working to achieve the patient’s weight loss goals.
- Adults who achieve at least 5% weight loss after 16 weeks of liraglutide therapy are more likely to achieve greater than 10% weight loss at one year than those with less early weight reduction. Those who responded well to liraglutide showed greater improvement in cardiometabolic risk factors versus early non responders.
- Sixty-nine percent of those with prediabetes at the start of the study had reverted to normoglycemia on liraglutide.
Pi-Sunyer, F. Xavier, et al. “PP05-4: Liraglutide 3.0 Mg Reduces the Prevalence of Prediabetes and Delays Onset of Type 2 Diabetes in Overweight and Obese Adults: Results from Scale Obesity and Prediabetes, a Randomized, Double-Blind and Placebo-Controlled 56-Week Trial.” (2014).
Davies, Melanie J., et al. “Efficacy of liraglutide for weight loss among patients with type 2 diabetes: The SCALE Diabetes Randomized Clinical Trial.” JAMA 314.7 (2015): 687-699.