TrialWatch December 1, 2011
A Performance Evaluation of the Enlite Glucose Sensor to Support a Full 144 Hours of Use
ClinicalTrials.gov Identifier: NCT01464346
In April, Medtronic’s new Enlite sensor received CE Mark approval for six-day wear in Europe. Designed to be more comfortable and accurate that previous Medtronic sensors (see our NewNowNext in diaTribe #32), the Enlite sensor had been highly anticipated worldwide. While the sensor is now on the market in Europe, it remains unavailable in the United States. Importantly, data from this pivotal trial will be included in the US submission of the Enlite sensor for the FDA’s consideration. This study aims to characterize the performance of the Enlite sensor over an entire calibration and wear period of six days when used with Medtronic’s newest insulin pump. The study will take place at two locations – the AMCR Institute in Escondido, CA, and Rainier Clinical Research Center in Renton, WA. To be eligible, participants must be 18-75 years old, and have been clinically diagnosed with type 1 diabetes or type 2 diabetes. In addition, participants must not be pregnant, have had a hypoglycemic seizure within six months prior, or have a history of cardiovascular disease. For a complete list of inclusion and exclusion criteria, please click here. If you are eligible and interested in participating, please contact Timothy Bailey (Escondido, CA) at 760-466-1530 or tbailey@amcrinstitute.com or Ronald Brazg (Renton, WA) at 425-271-1720 at rbrazg@rainier-research.com. --VW
Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON)
ClinicalTrials.gov Identifier: NCT01351675
As it currently stands, there are no treatments for chronic kidney disease (CKD; one of many unfortunate complications of diabetes) beyond controlling high blood pressure and blood sugar levels to prevent the development of irreversible kidney failure. Encouragingly, Reata Pharmaceuticals is developing a drug called bardoxolone that has in earlier studies been shown to improve kidney function in people with type 2 diabetes and CKD (see our NewNowNext in diaTribe #35). This study will assess the effectiveness of bardoxolone in delaying progression to end-stage renal disease (ESRD) and cardiovascular death for people with type 2 diabetes and CKD. If results from this study confirm that bardoxolone indeed improves kidney function, the drug could be approved as early as 2014. To be eligible, participants must be at least 18 years old, have type 2 diabetes, have a screening estimated glomerular filtration rate (eGFR; a measurement of kidney function) of between 15 and 30 ml/min/1.73 m2, and have been treated with an ACE inhibitor (e.g., Vasotec, Renitec, Altace, Accupril) or an ARB (e.g., Avapro, Micardis, Teveten, Benicar, Edarbi) for at least six weeks prior to and during screening. In addition, participants must not have known non-diabetic renal disease, history of a renal transplant, A1c >11.0%, or recent cardiovascular disease. For a complete list of inclusion and exclusion criteria, please click here. The study is recruiting at 177 sites across the US and several international locations – for contact information, please click here. --VW