New Diabetes Drug Cycloset Approved
Cycloset Targets Brain Chemical Dopamine to Treat Type 2 Diabetes
May 7, 2009 -- The FDA has approved a new drug, called Cycloset, to improve blood sugar control in adults with type 2 diabetes, in addition to diet and exercise.
Cycloset takes a new approach to treating type 2 diabetes. It boosts levels of a chemical called dopamine, which helps nerve cells communicate.
Cycloset is taken orally in the morning, within two hours of waking, and with food.
It's not clear how Cycloset improves glycemic control in humans. But studies in diabetic animals show that boosting dopamine activity at a particular time of day can "reset" the biological clock to improve metabolism problems related to diabetes, according to VeroScience, the company that developed Cycloset.
In a yearlong trial of 3,070 adults with type 2 diabetes, Cycloset trumped a placebo at improving HbA1c levels, which gauge blood sugar control, over the previous two to three months. In that trial, 39% of patients taking Cycloset met the HbA1c goal, compared to 11% of patients taking the placebo.
In addition, patients taking Cycloset were less likely to have a heart attack or stroke, or to die of heart disease.
During the clinical trial, 24% of the patients in the Cycloset group dropped out of the study, compared to 15% of the patients taking placebo. Gastrointestinal side effects, particularly nausea, were the main reason patients taking Cycloset quit the study.
The most commonly reported adverse events were nausea, fatigue, vomiting, headache, and dizziness. None of those cases was serious, and side effects were more likely to happen when patients first started taking Cycloset.
Cycloset's active ingredient, bromocriptine mesylate, isn't a new drug. It's been used in other formulations to treat conditions including Parkinson's disease, usually at higher doses, according to Cycloset's prescribing information.