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Item #15 

New “GOT” Study to Help 6000 Type 2’s Achieve Glycemic Control

GOT (Glycemia Optimization Treatment), will examine whether varying dosing regimens of insulin in combination with oral agents will help patients with type 2 diabetes meet the AACE goal of an A1c of less than 6.5% 

Insulin therapy can effectively help patients with diabetes achieve tight blood sugar control, defined by the American Diabetes Association (ADA) as an A1C<7.0%, however, many physicians delay or inadequately dose insulin for fear that such tight control could possibly lead to hypoglycemia (low blood sugar).   

Aventis Pharmaceuticals announced the launch of this second large-scale clinical study to help determine optimum dosing regimens of Lantus^Ò (insulin glargine [rDNA origin] injection) in combination with oral medications.   

“The GOT trial is an important step in improving physician understanding of how intensive treatment strategies are possible and can achieve tight control while at the same time observing the circumstances that lead to hypoglycemic events,” said investigator Ariel Zisman, MD, Assistant Professor of Medicine, University of Miami School of Medicine. “Despite the availability of effective treatments today, achieving tight control without inducing hypoglycemia remains a somewhat elusive goal in primary care.  The GOT study will help determine whether these events are related to the treatment regimen or to circumstances that, when addressed with education, may be reversible.” 

Hypoglycemic events are often linked to events such as skipping a meal, unusually strenuous exercise, sickness, or other events suggesting that educating patients on the proper use of insulin and monitoring and follow-up communications with patients may help reduce the number and severity of these events. 

“Although tight glycemic control is achievable, less than half of the more than 11 million Americans diagnosed with diabetes are meeting the blood sugar goals established by clinical guidelines, including an A1C <7%,” said Michael Pfeifer, M.D., medical product leader at Aventis Pharmaceuticals.   

According to a new study by the U.S. Department of Health and Human Services, the nation now spends $13,243 on each person with diabetes, compared to $2,560 for people without the disease.  This represents a direct medical cost of $91.8 billion.  In making the announcement, Francine R. Kaufman, M.D., president of the American Diabetes Association called on the nation to “eliminate or reduce the health problems caused by diabetes through more intensive disease management and use of new medical technologies and treatments.”  

The GOT trial is a U.S.-based, prospective, open-label trial, involving more than 6,000 type 2 diabetes patients in the U.S. from about 1,200 primary care physicians’ offices.  A previous study has shown that 57% of patients treated with Lantus^Ò reached the A1C target of less than 7.0% with a low incidence of hypoglycemic events. 

For more information on the GOT trial and GOAL A1C, visit www.GOALA1C.com