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Diabetic Kidney Disease (also called Diabetic Nephropathy) is a condition that affects many patients with both Type 1 and Type 2 Diabetes. The Kidneys work as a filtering system in the body and when a Diabetic’s blood glucose levels remain high for prolonged periods of time, the kidneys are forced to filter larger amounts of blood. This causes enormous strain on the kidneys. Over time, the Kidney’s ability to perform their primary function decreases. This can lead to waste products building up in the blood stream and eventually the kidneys can fail, leading to undesirable options such as dialysis and kidney transplantation.


A Diabetic who is in the stages of kidney (renal) impairment must be closely monitored by their physician and medical team to achieve a balance between controlling their blood sugar (so that further kidney damage does not occur), and adjusting the Diabetic medication doses (to prevent harmful potentially toxic drug levels from building up). Often, the physician will check the patient’s kidney function on a routine basis. This is usually done by a simple blood test, and those results along with the patient’s age and gender are factored in to determine what is called the GFR (or glomerular filtration rate). The Glomeruli are the “mini” filters in the patient’s kidneys that help filter out the waste products from food and medications that the patient ingests. A “normal” GFR is over 90. Diabetic patients often have levels way below this. When the level gets in the range of 30-60, this is what is called “Moderate Kidney Impairment” and must be monitored very closely to prevent the patient from having to consider dialysis or transplant scenarios.


Medications given to even mild and moderately impaired kidney function can be tricky for the physician and the treatment team to manage. Many drugs are metabolized in the liver and kidneys and excreted through the urine. When the kidneys are impaired and cannot filter out the medications and waste, toxic levels of these drugs can build up in the bloodstream and can cause unpleasant or even harmful side effects. Many times, the glucose lowering medication dose have to be decreased in these patients to prevent toxicity (and some medication cannot be used at all), but this can cause the patients’ blood sugar levels to increase which, in turn, damage the kidneys more. This vicious circle is where an intense amount of research concentrating in finding treatments that can decrease blood glucose levels with minimal or no further damage to the kidneys is occurring.


One of the newer classes of investigational drugs that are being studied in the lowering of blood glucose levels are called SGLT2 Inhibitors. SGLT2’s are transporters in the kidneys that are primarily responsible for reabsorbing glucose back into the bloodstream after the kidney has filtered it. An SGLT2 inhibitor therefore decreases the amount of glucose reabsorbed and it is instead excreted (released) in the urine, thus lowering blood sugar levels. Some SGLT2 Inhibitors have already been approved for market use with favorable effects, and new ones are currently being tested in Clinical Research Studies.


With this potential new way of lowering blood glucose, ensuring that SGL2 inhibitors work as well and also do not cause any further damage on kidney impaired patients is essential. Currently, a clinical research study is being conducted in the West Palm Beach area at Metabolic Research Institute under the direction of Dr. William Kaye and Dr. Barry Horowitz, co-medical directors. The aim of this study is to see if a new SGLT2 inhibitor called Ertugliflozin is both effective and safe in lowering blood glucose levels in this patient population.


Ertugliflozin has been tested for this indication through many phases of the Clinical Trial process and the initial studies (Phase I and II Trials). The Phase III trial is now underway and one of the final steps before FDA approval. One of the final steps involves an intense look at whether or not this study medication can help Diabetic Nephropathy patients with moderate kidney impairment. This Phase III Trial is being conducted in the West Palm Beach area at Metabolic Research Institute under the direction of Dr. William Kaye and Dr. Barry Horowitz, co-medical directors.


There is no cost to the participant to enroll. All study medications, blood work, study-related exams and other research-related procedures are provided by Metabolic Research Institute and the pharmaceutical company that sponsors the trial. Participants may receive compensation for their time and travel.



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