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New Data Show Investigational Compound Dapagliflozin When Added To Glimepiride Maintained Reductions In Blood Sugar Levels In Adults With Type 2 Diabetes Over 48 Weeks Of Treatment

Hypoglycemic events were more frequent in the dapagliflozin groups (9.7% in 2.5 mg group, 10.3% in 5 mg group, 11.3% in 10 mg group) compared to the placebo group (6.8%), with no patients discontinuing treatment due to hypoglycemia. There was one major episode of hypoglycemia in the dapagliflozin 2.5 mg group.

The percentage of patients with events suggestive of genital infections was higher for dapagliflozin added to glimepiride compared to placebo added to glimepiride, as follows: 5.2% with dapagliflozin 2.5 mg, 6.2% with dapagliflozin 5 mg and 8.6% for dapagliflozin 10 mg compared to 1.4% with placebo added to glimepiride. Overall, events suggestive of genital infections were higher in females than in males.

The percentage of patients with events suggestive of urinary tract infections was similar across treatment groups, as follows: 4.5% with dapagliflozin 2.5 mg, 7.6% with dapagliflozin 5 mg and 7.9% for dapagliflozin 10 mg compared to 7.5% with placebo added to glimepiride. Overall, events suggestive of urinary tract infections were higher in females than in males.

No kidney infections were reported in the study.

About Type 2 Diabetes

In 2011, diabetes was estimated to affect more than 365 million people aged 20-79 worldwide. Because of the aging population and the growing trend of obesity, the prevalence of diabetes is projected to reach more than 550 million by 2030. Type 2 diabetes accounts for approximately 90 to 95% of all cases of diagnosed diabetes in adults. Type 2 diabetes is a chronic, progressive disease characterized by insulin resistance and/or dysfunction of beta cells in the pancreas, which decreases insulin sensitivity and secretion, leading to elevated glucose levels. Over time, this sustained hyperglycemia contributes to worsening insulin resistance and further beta cell dysfunction. To date, treatments for type 2 diabetes have focused primarily on insulin-dependent mechanisms. An approach that acts independently of insulin could provide an additional option for adults with type 2 diabetes.

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