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The Largest Ever Study of Diabetes Shows Intensive Glucose Control Reduces Serious Complications

SAN FRANCISCO, California, June 6 /PRNewswire/ --

- "ADVANCE Results go Beyond Existing Evidence"

New results from the world's largest ever study of diabetes treatments show that intensive blood glucose (sugar) control using modified release gliclazide and other drugs as required, protects patients against serious complications of the disease. In particular, intensive treatment reduces the risk of kidney disease by one-fifth. Presented today at the American Diabetes Association and published in the New England Journal of Medicine, the results of ADVANCE (Action in Diabetes and Vascular Disease) show that this intensive treatment strategy has the potential to benefit millions of diabetic patients worldwide.

Diabetes mellitus is one of the greatest threats to the health of populations worldwide. Globally, there are approximately 250 million people with diabetes and that number is estimated to rise to 380 million in 2025.

Chief investigator of the study, Professor Stephen MacMahon, Principal Director of The George Institute, Australia said "We are facing a global epidemic of diabetes. The ADVANCE results go beyond existing evidence as we have now shown that reducing the haemoglobin A1c level (a marker of blood glucose control) to 6.5% is a safe and effective way to reduce serious complications, particularly the risk of kidney disease, one of the most serious and disabling consequences of diabetes, leading to death in one in five people with diabetes."

"Hypoglycemia (low blood sugar) was uncommon in the ADVANCE study, although as expected it was more frequent among those receiving intensive treatment," pointed out Study Director, Associate Professor Anushka Patel from The George Institute. "These findings reinforce that blood glucose lowering in diabetes is safe and has an important role to play in the prevention of serious complications."

"Moreover, in contrast to the recently halted ACCORD study, there was no evidence whatsoever of any increased risk of death among those receiving intensive treatment in ADVANCE."

ADVANCE was initiated and designed by physicians at Australia's George Institute for International Health and involved a group of independent medical researchers from 20 countries worldwide. The study involved 11,140 patients with type 2 diabetes who were treated and followed up for five years. The study aimed to reduce levels of haemoglobin A1c to 6.5% or below. Intensive treatment included the sulfonylurea, modified-release gliclazide, for all patients and other drugs as required to achieve the haemoglobin target.

The major findings of ADVANCE show that intensive blood glucose lowering treatment:

- Safely controlled blood glucose to a mean HbA1c level of 6.5%

- Significantly reduced the overall risk of serious diabetes

complications (by 10%), with a one-fifth reduction in kidney disease

(21%) and 30% reduction in the development of proteinuria, a well

established marker of increased cardiovascular risk.

- Achieved a positive trend towards reduction in the risk of

cardiovascular death (12%), although not statistically significant.

"Today, it is clear that the prevention of major vascular complications of diabetes requires a multi-factorial approach addressing all modifiable risk factors," concluded Professor John Chalmers, chairman of the study management group, "among which an intensive glucose control plays an important role, in particular in protecting the kidneys."

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