Boehringer Ingelheim (Canada) Ltd. and Eli Lilly Canada announced that Health Canada has approved Jardiance (empagliflozin) to be used as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes.
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.2 Jardiance lowers the renal threshold for glucose, which leads to reduced renal reabsorption of filtered glucose and increased urinary glucose excretion.1
"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.
Jardiance is indicated for use as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus for whom metformin is inappropriate due to contraindications or intolerance. It is indicated for use in adult patients with type 2 diabetes mellitus to improve glycemic control, when metformin used alone does not provide adequate glycemic control, in combination with metformin, metformin and a sulfonylurea, pioglitazone (alone or with metformin), basal or prandial insulin (alone or with metformin), when the existing therapy, along with diet and exercise, does not provide adequate glycemic control.
The recommended starting dose of Jardiance is 10 mg once daily at any time of the day with or without food. The dose can be increased to 25 mg once daily for patients who require additional glycemic control and tolerate the 10 mg dose.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centres on three pipeline compounds representing several of the largest treatment classes.