Health Canada approves Jardiance tablets for adults with type 2 diabetes

Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

Jardiance belongs to a new class of agents called sodium glucose co-transporter 2 (SGLT2) inhibitors that have a different mechanism of action from other oral glucose-lowering agents. Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.

"Although there are many medications available for the treatment of type 2 diabetes, one in two people are not achieving the recommended glycemic goals," says Dr Ronald M. Goldenberg, Endocrinologist at LMC Diabetes and Endocrinology in Thornhill, Ontario. "The approval and availability of Jardiance gives Canadian physicians another option to help improve glycemic control."

Empagliflozin was studied as a single agent (monotherapy) and in combination with other antidiabetic medications, including metformin, metformin and sulfonylurea, pioglitazone (with or without metformin), and basal and prandial insulin (with or without metformin).

Empagliflozin was also studied in patients with type 2 diabetes and cardiovascular disease, and in patients with different degrees of renal impairment.

Treatment with empagliflozin resulted in statistically significant improvements from baseline at Week 24 in HbA1c, fasting plasma glucose (FPG), and body weight across a range of background therapies. In the double-blind placebo-controlled extension of these studies, reductions of HbA1c and body weight were sustained up to Week 76. HbA1c reductions were also seen across subgroups including gender, age, race, duration of disease, and baseline BMI.

In clinical studies, the most common adverse event with empagliflozin was hypoglycaemia, which depended on the type of background therapy used in the respective studies. Other common adverse events included urinary tract infections, genital mycotic infections, increased urination, upper respiratory tract infections and dyslipidemia.