Ralph A. DeFronzo
Tanzania
Research Article
Randomized Clinical Trial Assessing the Efficacy and Safety of Bromocriptine-QR when Added to Ongoing Thiazolidinedione Therapy in Patients with Type 2 Diabetes Mellitus
Author(s): Hermes Florez, Richard Scranton, Wildon R. Farwell, Ralph A. DeFronzo, Michael Ezrokhi, J. Michael Gaziano and Anthony H. CincottaHermes Florez, Richard Scranton, Wildon R. Farwell, Ralph A. DeFronzo, Michael Ezrokhi, J. Michael Gaziano and Anthony H. Cincotta
Aims: To evaluate the glycemic control efficacy and cardio-metabolic safety of bromocriptine- quick release (Bromocriptine-QR) among subjects with type 2 diabetes who were taking a thiazolidinedione (TZD) at baseline.
Methods: A subgroup from the Cycloset Safety trial who were taking a TZD at baseline with or without another oral anti-diabetes medication were randomized to receive additional once daily (morning) bromocriptine-QR (1.6 - 4.8 mg/day) or placebo for up to 52 weeks. Glycemic efficacy analyses were based on intent to treat modified (ITTm) and evaluable per protocol (EPP) population using general linear model after adjusting for baseline covariates and stratified by A1C level of <7.5 of ≥7.5. The odds ratio of participants achieving A1C ≤7% were calculated. Similar analyses for safety were performed on w.. View More»
