SOURCES: Melanie Davies, M.D., professor, diabetes medicine, University of Leicester, U.K.; Joel Zonszein, M.D., director, Clinical Diabetes Center, Montefiore Medical Center, New York City; Aug. 18, 2015, Journal of the American Medical Association
TUESDAY, Aug. 18, 2015 (HealthDay News) -- High doses of the diabetes drug liraglutide seem to help patients with type 2 diabetes lose weight, a new study suggests.
In a trial funded by the drug's maker Novo Nordisk, people who took 3 milligrams (mg) of liraglutide daily over 56 weeks lost an average of 6 percent of their body weight (14 pounds).
According to Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City, the U.S. Food and Drug Administration has approved a 3 mg-dose of liraglutide for the treatment of weight loss only. That higher dose is sold under the brand name Saxenda. A lower dose of liraglutide (up to 1.8 mg a day) is approved for the treatment of type 2 diabetes and is sold under the brand name Victoza.
"This is the first study specifically designed to investigate the efficacy of liraglutide for weight management in patients with type 2 diabetes at a dose of 3 mg, and not surprisingly was found to be effective and tolerated for weight loss," said Zonszein, who was not involved in the trial.
"We need these studies, as clinicians have a big problem trying to use higher doses of liraglutide in obese patients who have diabetes. Hopefully, the FDA will change the arbitrary restrictions," he added.
In the study, 846 overweight or obese patients with diabetes were randomly assigned to 1.8 mg or 3 mg of liraglutide or a placebo daily. Those who took 1.8 mg lost an average of close to 5 percent of their body weight (11 pounds), while patients taking a placebo lost an average of 2 percent of their body weight (almost 5 pounds), the researchers reported.
According to the study, published Aug. 18 in the Journal of the American Medical Association, 54 percent of those receiving the 3 mg-dose lost at least 5 percent of their body weight, compared with slightly more than 40 percent of those on the 1.8 mg dose and just over 21 percent of those taking a placebo.
Moreover, just over 25 percent of those on the high dose of liraglutide lost at least 10 percent of their body weight, compared with 16 percent of those on the 1.8 mg-dose and close to 7 percent of those taking a placebo. Patients also followed a reduced-calorie diet and increased their physical activity, the researchers noted.
"We now have evidence that supports the use of the 3 mg-dose for weight loss in patients with type 2 diabetes," said lead researcher Dr. Melanie Davies, a professor of diabetes medicine at the University of Leicester in the U.K.
In people with diabetes, the 3 mg-dose of liraglutide helped patients achieve clinically significant weight loss and more than 50 percent of patients were able to achieve a weight loss of more than 5 percent, she said. "Also, this higher dose of [liraglutide] provided additional blood sugar-lowering than the dose currently licensed to treat patients with diabetes," she added.
Zonszein noted that since the higher dose of liraglutide is not approved to treat diabetes, insurance companies will not cover the cost of the drug when it is prescribed to diabetics.
"We can prescribe up to 1.8 mg for diabetes, that is the highest dose, but insurance companies will not approve the 3 mg-dose for diabetes," he said.
Liraglutide is expensive, Zonszein added, and the 3 mg-dose can cost $800 to $1,000 a month. Insurance covers the cost only when that dose is prescribed for weight loss.
Zonszein sees no problem using the higher dose to control blood sugar as well as to help patients lose weight. Liraglutide is part of a drug regimen to control blood sugar that can include metformin and other drugs, he explained.
To get insurance companies to cover the higher dose for a diabetic patient, Zonszein said he has to use a workaround. "When we call an insurance company for approval, we don't tell them the patient is diabetic, but is obese," he said.
For more on type 2 diabetes, visit the American Diabetes Association.