A study recently published in the journal JAMA revealed new data on a Phase 3 clinical trial assessing the efficacy of liraglutide for weight loss in patients with type 2 diabetes. The trial was sponsored by Novo Nordisk and conducted by an international team of researchers. The article is entitled “Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes The SCALE Diabetes Randomized Clinical Trial.”
It is known that obesity causes a systemic inflammatory state in the body and is associated with the development of several disorders including heart disease, certain types of cancer and type 2 diabetes.
Type 2 diabetes is the most common form of diabetes, affecting 90 to 95% of the individuals diagnosed with the disease. Patients with type 2 diabetes do not make enough insulin or do not use it properly, leading to insulin resistance and eventually to higher blood sugar levels (hyperglycemia). Insulin is a hormone essential to controlling blood sugar levels and converting sugar, starches and other foods into energy.
It has been previously reported that a weight loss of 5 to 10% in obese patients can improve type 2 diabetes and associated comorbidities. However, only a few effective drugs are currently available for weight management.
Liraglutide (known by brand name Victoza, by Novo Nordisk) is an injectable long-acting glucagon-like peptide-1 receptor agonist developed for the treatment of type 2 diabetes (but is not currently indicated for chronic weight management or for use in people who do not have type 2 diabetes). Liraglutide known under the brand name Saxenda, while not indicated for the treatment of type 2 diabetes, has been approved for the treatment of obesity.
Researchers conducted a Phase 3 clinical trial (NCT01272232) to assess the safety and efficacy of liraglutide in weight management in type 2 diabetes patients who are overweight or obese.
The trial included a 56-week randomized, placebo-controlled, double-blind study with a 12-week observational off-drug follow-up period. The trial was conducted between June 2011 and January 2013 and involved 126 sites in 9 different countries. In total, 846 participants were analyzed. They were all aged 18 years or older and had a body mass index of 27.0 or greater. Participants were randomly divided into three groups that either received once daily subcutaneous liraglutide (3.0 mg; 423 patients), liraglutide (1.8 mg; 211 patients), or a placebo (212 patients). Participants also underwent a dietary deficit of 500 kcal/day during the trial and increased physical activity (150 min or more per week). The team evaluated weight changes and the proportion of participants losing 5%, 10% or more of the baseline weight at week 56.
Researchers found that the weight loss at the end of the 56 weeks was on average 6% in the group receiving 3 mg liraglutide, 4.7% in patients receiving 1.8 mg liraglutide and 2% in the placebo group. A weight loss of 5% or greater was observed in 54.3% of the patients given 3 mg liraglutide, 40.4% of the patients receiving 1.8 mg liraglutide and 21.4% in the placebo group. A weight loss of 10% or greater occurred in 25.2% of the patients under 3 mg liraglutide therapy, 15.9% under 1.8 mg liraglutide and 6.7% in the placebo group. In terms of adverse effects, more gastrointestinal events were reported by patients receiving 3 mg of liraglutide in comparison to the group receiving 1.8 mg dose or a placebo.
The research team concluded that the daily subcutaneous administration of liraglutide in overweight and obese patients with type 2 diabetes can induce weight loss in a period of 56 weeks. The authors refer that further studies should be conducted to evaluate the long-term benefits and safety of liraglutide therapy.