With commentary by Robert Kushner, MD, professor of medicine and endocrinology at Northwestern University's Feinberg School of Medicine
The drug liraglutide, taken at high doses, helps many with type 2 diabetes shed pounds, new research has found.
"For patients who present with type 2 diabetes and obesity, use of liraglutide 3.0 mg is a unique medication that can address both chronic medical conditions," says Robert Kushner, MD, professor of medicine and endocrinology at Northwestern University's Feinberg School of Medicine, Chicago, and a study researcher. Experts know that a weight loss of 5 to 10 percent of body weight can help those with type 2 diabetes improve their condition and the other risks that accompany it, such as heart disease.
The study results were published Aug. 18 in the Journal of the American Medical Association. Novo Nordisk, the drug's maker, funded the trial, known as the SCALE Diabetes Randomized Clinical Trial.
Dr. Kushner and other researchers from several institutions in the U.K. and the U.S. randomly assigned 846 men and women who had diabetes to either the 3 mg. group, the 1.8 mg group, or the placebo group. All groups were advised to reduce their caloric intake by 500 calories a day and to increase their physical activity to 150 minutes a week or more. The study was conducted beginning in June 2011 and ran through January 2013.
All those in the study were overweight, with a body mass index (BMI) of 27 or higher. A BMI of 30 and higher is termed obese. The average weight of the participants was about 230 pounds. The men and women administered the drugs and placebo as an injection under the skin, using an insulin pen device. Those in the high dose group lost 6 percent of their body weight, or about 14 pounds. Those in the lower dose lost 5 percent, or about 11 pounds. Those on placebo lost only about 2 percent of their starting weight.
The higher dose drug also produced more lowering of blood sugar than the lower dose did, the researchers found. Side effects were more common in the drug groups than the placebo groups. Most common was nausea, vomiting, diarrhea and constipation.
While the results are considered encouraging, one stumbling block is that the higher dose is not approved for diabetes treatment in the U.S. For that reason, insurance companies will not cover it when the doctor prescribes the higher dose for diabetes. Drug costs are substantial. The 3 mg dose can be about $1,000 a month. The lower dose can be about $500.
"Coverage is a significant problem for all anti-obesity medications," Dr. Kushner says. He is hopeful that pressure to encourage insurers to cover the medicine will be successful, with the argument to cover them supported by findings from the research.
Despite the generally good results for weight loss with the higher dose, Dr. Kushner says it is important for doctors to discuss realistic expectations and outcomes. People respond to the medicine in different ways, with some losing more weight than others.
The finding from the new study that the higher dose produces more weight loss is no surprise, says Maria Pena, MD, director of the Center for Weight Management at Lenox Hill Hospital, New York. She reviewed the findings. She has prescribed the drug for her patients with diabetes.
She says she first noticed the weight loss effect with some of her patients on Victoza. "Even on the low dose, we noticed weight loss," she says. The drug mimics a hormone made in the intestines that tells your brain it is full, experts say.
The downside, Dr. Pena agrees, is the cost of the drugs. "These medications are very expensive."