A best-selling diabetes drug showed in recent tests that it may aid weight loss for people with and without diabetes. However, it is not a pop-a-pill-and-lose-weight panacea. The test subjects also were on diet and exercise programs.
Results from a late-stage clinical trial presented this weekend showed that Victoza, Danish drug company Novo Nordisk’s injectable diabetes product, helped both diabetics and nondiabetics lose weight. They lost almost two to three times as much weight as others on the same diet and exercise programs who took placebos.
People who injected liraglutide (Victoza) during the study lost, on average, 8 percent of their body weight. Those taking a placebo only lost 2.6 percent.
The 56-week study had 846 participants who were obese or overweight adults with type 2 diabetes. The study participants who took a daily 3 milligram dose of liraglutide had a mean loss of 5.9 percent of their body weight. In fact, half the patients taking 3 mg lost at least 5 percent of body weight. In addition, 22 percent dropped more than 10 percent.
Those study participants who took 1.8 milligrams daily, which is a common prescription level for diabetes, lost 4.6 percent. Those who only received a placebo lost just 2 percent loss of their body weight.
Weight loss has been viewed for years as a side effect of diabetes drug Victoza. However, with the growth of obesity worldwide as a health, its manufacturer sees a possible gold mine if the diabetes drug can be proven and approved as a weight loss drug. In the U.S. alone, two-thirds of adults are considered to be overweight.
While weight loss has been a positive side effect of Victoza, the drug has been controversial for its negative affects. Consumer groups have called for its removal from the market claiming it raises thyroid cancer and pancreatitis risks. The FDA, however, has defended Victoza’s safety. Kushner said there were no cases of either during the trial. He believes the benefits outweigh the drug’s risks.
Those who participated in the weight loss study also experienced negative side effects. Almost 10 percent of those in the 3-milligram dosage group dropped out. The majority of the dropouts reported that the medication gave them gastrointestinal problems, such as diarrhea and nausea. Those are common side effects for drugs in this class, as typically diminish within four to eight weeks, but the dropouts did not wait to confirm that the issues go away.
As a diabetes drug, Victoza generated global sales of approximately $542 million the first three months of 2014. It is approved in the U.S. and Europe to treat type 2 diabetes in the United States at 1.2 and 1.8 milligram dosages. Novo Nordisk is hoping for approval from U.S. and European regulators for a 3 milligram level for prescribing as a weight loss aid.
“It stacks up very favorably against other medications that are out there or likely to be approved,” according to Dr. Robert Kushner, one of the trial’s investigators. That efficacy should help satisfy the U.S. Food and Drug Administration weight loss aid medication criteria, but the diabetes drug’s safety may still be a high hurdle before approval. A lively debate is expected when Victoza is discussed in September before the FDA makes a decision.
By Dyanne Weiss