Santarus Launches Cycloset, A Novel Drug Treatment for Type 2 Diabetes

In mid-November, Santarus Inc. announced the launch of Cycloset, a novel, weight-neutral, glucose-lowering drug for type 2 diabetes. Cycloset is a quick-release formulation of bromocriptine, which acts directly on the brain by binding to dopamine receptors (the binding of molecules to dopamine receptors is responsible for a number of effects in the body, including the modulation of insulin resistance in some animals). Although the specific means by which Cycloset brings about improvements in glycemic control remain largely unknown, in a clinical trial, the drug was shown to lower A1c by 0.6% to 0.9% when added to other oral antidiabetic medications, from a base of 8.3%. In addition, a clinical study of Cycloset found that, when taken once daily within two hours of waking, Cycloset can provide reductions in post-meal glucose levels throughout the day. This improvement happens without increasing plasma insulin concentrations, suggesting a possible effect on insulin sensitivity. Importantly, data from clinical trials for Cycloset suggest that it may even lower cardiovascular risk – a huge benefit considering most people with type 2 diabetes are at increased risk for heart disease. Safety data have been encouraging for Cycloset, and the active component in the drug (bromocriptine) is generally regarded as safe after many years of approved use for the treatment of Parkinson's disease. Considering Cycloset's modest efficacy in lowering blood glucose levels, its safety profile, and its novel mechanism, the drug seems like a candidate that could have some valuable use in combination therapy for type 2 diabetes.   --VW