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news.Santarus has launched Cycloset (bromocriptine mesylate) tablets, approved by the US Food and Drug Administration (FDA) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus both as monotherapy and in combination with other oral antidiabetic agents, in the US.
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In a 24-week, placebo-controlled, monotherapy study of the impact of Cycloset on glycemic control in 159 overweight adults (BMI = 26.0kg/m2 for males and = 28.0kg/m2 for females) with type 2 diabetes and baseline HbA1c of 7.5% – 11% indicated that once-daily morning dosing of Cycloset provided postprandial plasma glucose reductions throughout the day without increasing plasma insulin concentrations and significantly improved HbA1c.
Santarus president and CEO Gerald Proehl said that they are pleased to announce that Cycloset is now available through retail pharmacies.
University of Texas Health Sciences Center diabetes division chief Ralph DeFronzo said that Cycloset represents a new treatment for adults with type 2 diabetes.
"Although the mechanism by which Cycloset improves glycemic control is unknown, it contains bromocriptine mesylate, which increases dopaminergic activity in the hypothalamus," DeFronzo said.
"In a clinical trial, Cycloset lowered HbA1c by 0.6% to 0.9% relative to placebo, when added to other oral antidiabetic agents. Cycloset can be prescribed for adults who are inadequately controlled with diet/exercise, metformin, sulfonylureas or thiazolidinediones."