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Novel Diabetes Drug Approved

Darrell Hulisz, RPh, PharmD
Heather Armbrus

May 29, 2013

Canagliflozin (Invokana®) belongs to a new class of medications known as the sodium-glucose co-transporter 2 (SGLT2) inhibitors. Canagliflozin recently received FDA approval as an adjunct to diet and exercise in patients with Type 2 diabetes.1 This new class of drugs inhibits reabsorption of glucose by the kidneys causing decreased blood glucose and increased urine glucose concentrations.

In a phase III trial comparing canagliflozen 300mg to sitagliptin 100mg, each administered once daily in combination with metformin and a sulfonylurea, canagliflozen decreased hemoglobin A1C (HbA1C) levels at 52 weeks by 1.03% compared to 0.66% with sitagliptan.2 Canagliflozen also significantly reduced body weight by an average of 2.3 kg and systolic blood pressure by an average of 5.1 mmHg. A notable side effect was increased genital fungal infections, which occurred in 9.2% of male and 15.3% of female subjects who received cangliflozen.

Canagliflozen's effects on weight and blood pressure were significant and if further confirmed, would represent a unique advantage relative to other oral diabetic medications. The FDA is requiring that additional post-marketing studies be conducted, including cardiovascular outcomes and pharmacovigiliance trials. Canaglifozen should be avoided in patients who have impaired renal function.

It is likely that the FDA will approve additional SGLT2 inhibitors. Applications have recently been submitted seeking the approval of empaglifozen in the US and ipragliflozen in Japan. A similar drug, dapagliflozin is already approved in Europe, but was denied approval in the US.

1. FDA. FDA approves Invokana to treat type 2 diabetes. March 29, 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm

2. Schernthaner G, Gross JL, Rosenstock J, et al. Canagliflozin compared with sitagliptin for patients with type 2 diabetes who do not have adequate glycemic control with metformin plus sulfonylurea. Diabetes Care 2013;2013 Apr 5.[Epub ahead of print].

3. Nainggolan, L. FDA approves canagliflozin, a first-in-class diabetes drug. Medscape Today. March 29, 2013. http://www.medscape.com/viewarticle/781709

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