*Findings from a 52-week, 74-center, randomized placebo-controlled trial to evaluate the safety of CYCLOSET. 3,070 patients were randomized 2:1 to add either CYCLOSET or placebo, respectively, to their current antidiabetic regimen, which could consist of diet alone or no more than 2 agents (2 OADs or insulin + 1 OAD). Inclusion criteria: age 30-80, BMI <43 kg/m, diagnosis of type 2 diabetes of > 6 months with an A1C ≤10.0% with no lower A1C boundary. Patients with a history of CVD and CHF were included in the trial.
Although the exact way that CYCLOSET works is not completely understood, it is known that it mimics the job done in the brain by a natural hormone called dopamine. In clinical studies, CYCLOSET significantly lowered blood sugar and improved A1C in adult patients with type 2 diabetes. One of the most common side effects of CYCLOSET is low blood sugar. This is especially likely if you are taking a type of diabetes medicine known as a sulfonylurea.
Patients with type 2 diabetes are thought to have low levels of dopamine activity in the morning. These low levels of dopamine may interfere with the body’s ability to control blood sugar.
CYCLOSET is a quick-release formulation of bromocriptine, a chemical compound that increases dopamine receptor activity. Unlike other medications for type 2 diabetes, CYCLOSET works by increasing dopamine receptor activity in the morning, which lowers blood sugar—without increasing insulin.
You take CYCLOSET just once each morning, when dopamine levels are low. This is when it works. And, you can take CYCLOSET alone or with other medicines that have been prescribed for you.
CYCLOSET has a demonstrated cardiovascular safety profile. In a year-long clinical study with 3,070 patients, CYCLOSET showed no increase in serious events such as heart attack or stroke. In the same study, CYCLOSET also demonstrated overall safety.
CYCLOSET tablets are taken once daily by mouth within 2 hours after waking in the morning. When you start taking CYCLOSET, you will take 1 tablet a day. The therapeutic dose of CYCLOSET is 2 to 6 tablets a day. The exact number of tablets varies. Your healthcare provider will tell you how to increase the number of tablets you take each day until you have reached a dose that is right for you.
CYCLOSET can help lower and control your blood sugar throughout the day. Get more details about:
CYCLOSET tablets should be taken once a day within two hours of waking and with food.
CYCLOSET is available by prescription only. For additional information, talk to your doctor and see Full Prescribing Information including Patient Labeling.
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Reference: Data on file, Santarus, Inc.