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Cycloset Data to Be Presented in Poster Session at 8th Annual World Congress ...
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SAN DIEGO & TIVERTON, R.I., Nov 04, 2010 (BUSINESS WIRE) -- Santarus, Inc. /quotes/comstock/15*!snts /quotes/nls/snts ( SNTS 3.34 , +0.04 , +1.21% ) and VeroScience LLC today announced that analyses of 379-patient subset data from a 3,070-patient Phase III safety study conducted with CYCLOSET(R) (bromocriptine mesylate) tablets suggested that CYCLOSET as an add-on to oral antidiabetes drugs produced improvements in glycemic control irrespective of baseline duration of disease. The findings will be presented Thursday, November 4, 2010 in a poster session at the 8th Annual World Congress on Insulin Resistance, Diabetes & CVD (WCIR) in Los Angeles.
The poster, Duration of Type 2 Diabetes Illness Influence on the Glycemic Control Effect of Cycloset, a Quick Release Formulation of Bromocriptine (M Ezrokhi, et al, Abstract #123), featured a subset analysis of the safety study, investigating the relationship between duration of type 2 diabetes disease and response to treatment with CYCLOSET as an add-on therapy to one or two oral antidiabetes drugs. The subset included 379 patients who had a baseline HbA1c (%) of greater-than or equal to 7.5 and less-than or equal to 10.0, were taking one or two oral antidiabetes drugs (usual diabetic therapy, or UDT), had follow-up data at week 24 of the study and were greater-than or equal to 127 days drug-compliant. Changes in HbA1c were assessed using linear regression models adjusted for various covariates and stratified by duration of illness. HbA1c is a standard measurement of blood glucose used to determine the efficacy of antidiabetes agents.
The 379 subjects had a mean baseline HbA1c level of 8.3, and mean age was 58 years. The mean duration of type 2 diabetes was 8.1 years (tertiles of duration were defined as 8.56 years). For each tertile, the between group differences in HbA1c for patients treated with CYCLOSET plus UDT compared with those receiving placebo plus UDT were -0.86 (-0.66 CYCLOSET, +0.20 Placebo), -0.66 (-0.47 CYCLOSET, +0.18 Placebo), and -0.53 (-0.62 CYCLOSET, -0.10 Placebo), respectively (P
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