Last week, the U.S. Food and Drug Administration (FDA) approved a new drug for treating Type 2 diabetes. Called Cycloset, the drug is actually a new version of the older drug bromocriptine, which has been used at higher doses to treat people with Parkinson disease.
The new drug, which is to be taken once a day, within two hours of waking up, with food, has been shown to lower HbA1c levels (a measure of average blood glucose) in people with Type 2 diabetes more than a placebo. In a year-long study of over 3,000 adults, 39% of people taking Cycloset reached the study’s HbA1c goal, compared to 11% of people who took the placebo. According to Cycloset’s press materials, studies have also shown that one daily dose of the drug helps lower postmeal rises in people’s blood glucose levels all day.
According to animal studies, Cycloset works by boosting the activity of a chemical called dopamine in the brain. This, in turn, “resets” the body’s biological clock to help control its metabolism. Studies of the biological clocks of migrating birds and hibernating animals, which become more insulin resistant during certain times of the year, helped inspire this drug’s development.
People taking Cycloset in the 3,000-person study were also less likely to have a heart attack or stroke or to die of heart disease while taking the drug. Earlier this year, the FDA tightened heart-safety standards for new diabetes drugs (check out the Diabetes Flashpoints feature “FDA: Stifler or Savior?” for more details about this decision).
When this drug will reach the market is unclear, since its manufacturer, VeroScience, Inc., is a small company. An interesting article about this drug’s 20-plus year journey from laboratory to market appeared last week in The Boston Globe.