A quick release formulation of bromocriptine mesylate in patients with type 2 diabetes improves glycemic control and reduces diabetic cardiovascular complications.
VeroScience, LLC, in conjunction with its commercialization partner S2 Therapeutics, Inc., reported at the ADA’s scientific sessions the results of its Phase IIIb clinical trial supporting the overall and cardiovascular safety of Cycloset(TM) (A quick release formulation of bromocriptine mesylate) in subjects with type 2 diabetes. The study, which highlighted a significant reduction in the risk of diabetic cardiovascular complications in subjects treated with Cycloset(TM) compared to placebo, also confirmed the drug’s ability to improve glycemic control in subjects failing metformin plus sulfonylurea therapy.
The data were presented by the principle investigator, J. Michael Gaziano, MD, MPH, Cardiologist at Brigham and Women’s Hospital and Veteran Affairs Boston Healthcare System, Boston, MA as a late-breaking poster.
Cycloset(TM) is being investigated as a once-daily, timed oral therapy for type 2 diabetes that acts upon the central nervous system (CNS) to impact peripheral metabolism. The Phase IIIb trial was conducted in response to an approvable letter from the FDA requesting additional data on Cycloset(TM)’s cardiovascular safety.
The double-blind, multi-center trial’s 3,070 participants included subjects with type 2 diabetes between the ages of 30 and 80 with HbA1c less than or equal to 10.0 and BMI less than or equal to 43.
Participants randomized into the study were all on a treatment regimen for their diabetes, which could include either diet alone, up to two oral hypoglycemic agents, insulin alone, or insulin with no more than J. Michael Gaziano, MD, MPH, stated that, "We were particularly interested in assessing the potential of a cardiovascular benefit and we were excited to see that in this population and in a relatively short time period there were indications of a reduction in cardiovascular events among those treated with Cycloset(TM) compared to placebo."
The rate of any serious adverse event was similar between Cycloset(TM) subjects (8.6%) and placebo subjects (9.6%).
Participants on a combined therapy of metformin and sulfonylurea with a baseline HbA1c greater than or equal to 7.5, indicating suboptimal glycemic control (mean baseline HbA1c of 8.3), were subjected to a pre-specified secondary analysis focused on Cycloset(TM)’s ability to reduce HbA1c after 24 weeks of therapy. Those receiving Cycloset(TM) and completing 24 weeks of therapy (121 subjects) experienced a mean HbA1c reduction of 0.69 (P = 0.0002) compared to respective placebo (71 subjects) and a mean HbA1c reduction from baseline of 0.67. Moreover 39% of these Cycloset(TM) subjects, versus 11% of these placebo subjects, reached the American Diabetes Association target goal of an HbA1c level of 7.0 (P = 0.0004).
"With the favorable conclusion of this large one year safety study and additional information from other clinical studies, VeroScience intends to file an amended NDA with the FDA targeting late third or fourth quarter of 2007," according to Richard E. Scranton, MD, MPH, Chief Medical Officer, VeroScience and co-principle investigator of the Cycloset(TM) Safety Trial.
Cycloset(TM) is an oral, quick-release formulation of bromocriptine, a centrally-acting dopamine D2 receptor agonist. When given as a single timed (morning) daily dose, Cycloset(TM) is believed to act on circadian neuronal activities within the hypothalamus to reset abnormally elevated hypothalamic drive for increased plasma glucose, triglyceride, and free fatty acid levels in fasting and postprandial states in insulin resistant subjects. Results of published clinical studies suggest that treatment with Cycloset(TM) may improve hyperglycemia, glucose intolerance, hyperlipidemia, or aspects of insulin resistance, while maintaining body fat neutrality or inducing body fat reduction.
Data presented at the 67th Scientific Sessions of the American Diabetes Association during the Clinical Therapeutics/New Technology – Pharmacologic Treatment of Diabetes or its Complications
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