Trial of drug targets both diabetes and heart disease

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A diabetes trial starting at St. Joseph’s Hospital is testing a potential magic bullet to combat both diabetes and the often-deadly complications of heart disease.

St. Joseph’s is one of 29 Canadian sites – and about 1,200 sites around the world – taking part in the DECLARE study to test a novel agent called Dapagliflozin, which experts hope will become a much-needed new tool in the diabetes care “toolbox”. The purpose of the trial is to lower blood sugar in people with type 2 diabetes and prove it to be safe in heart disease.  About 80 per cent of people with diabetes will die as a result of a heart attack or stroke.

St. Joseph’s endocrinologist Dr. Irene Hramiak has recruited 25 patients with type 2 diabetes who are over age 40 and at high risk of heart disease or who have had a heart event, such as a heart attack.

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“Currently, there is only one drug available, Metformin,  for those with type 2 diabetes that has been found to be good for both diabetes and heart disease,” explains Dr. Hramiak, chair/chief of the Centre for Diabetes, Endocrinology and Metabolism and a scientist with Lawson Health Research Institute. “But you can’t just use one drug forever.  Diabetes is a progressive disease so we have to keep adding treatment. It’s not like other conditions where you can stay on the same pill for 20 years. With diabetes the loss of pancreatic function is ongoing. We always need more tools in the toolbox.”

Dapagliflozin works to block an enzyme in the kidney that pulls sugar back into the blood from the urine. By blocking the enzyme the sugar leaves the body by way of the urine and improves blood sugar levels.

Ironically, if the drug works effectively, sugar in the urine will be good news while many years ago it was considered bad news, says Dr. Hramiak.  Before blood glucose monitors became readily available, diabetes patients tested their urine as an indication of how they were managing their disease. If sugar in their urine was high, it meant that sugar in the blood was likely high. In the DECLARE study, sugar in the urine will mean the new drug is doing its job.

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“We’re changing how we think about diabetes treatment,” explains Dr. Hramiak.”We’re changing the dynamics in the kidney. Here’s an agent that in fact puts sugar in the urine as a form of treatment. The kidney is causing more sugar to leak out and the sugar in the blood is dropping.”

The hope, she adds, is that the drug is proven safe in diabetics with, or at higher risk of, heart disease.

About 17,150 patients worldwide will be taking part in the five-year study, which is being coordinated by the Timi Study Group in Boston, MA.